Mark Magnuson


Consultant


Professional with solid technical and compliance knowledge and skilled in product development of Class I, II, and III medical devices. Over 14 years of experience working with global medical device and combination product manufacturers.  Background in In Vitro diagnostics, combination products (e.g., drug-eluding stents), balloon and self-expanding stents, balloon catheters, drug delivery catheters, wire guides, needles, and embolic protection devices.

CORE COMPETENCIES

  • Research & Development/Product Development
  • Project Management/Project Leadership
  • Design Controls/Design History Files (DHFs)
  • Change Management/Change Controls
  • Device Master Records (DMRs)
  • Quality System Development/Support
  • Risk Management/FMEA/Hazards
  • Analysis Procedural Development/Audits
  • Process Development/Process Controls
  • Corrective and Preventative Actions
  • Process Validations (IQ/OQ/PQ)
  • 21 CFR Part 820/Part 210/Part 211
  • Operating Procedures/Work Instructions
  • ISO 9000/ISO 13485/ISO 14971
  • Molding/Injection/Insert/Over Molding
  • Training/Training Materials/Assessments
  • Extrusion Tool design/3D Modeling
  • Process Improvement/Methods/Tools

SELECTED ACCOMPLISHMENTS

  • Provided project leadership for Risk Management Process and Risk Management File under warning letter remediation effort including the following:
    • Led Team of Quality Assurance Engineers, Quality Systems Engineers, Technical Writers and Training Designers to create, release and implemented quantitative risk management process
    • Project Management and mentoring Risk Team effecting the establishment of Risk Management File deliverables (e.g., design FMEAs, process FMEAs and use FMEAs) compliant to risk management process and EN 14971:2012
  • Provided project leadership for Design History File remediation including the following:
    • Research and acquisition of DHF support documentation
      • Acquired/authored, approved, and released documents associated with:
        • Design Input and Output Requirements
        • Traceability Matrices
        • Verification and Validation protocols and reports
    • Review/evaluate criticality analyses, risk analyses , preliminary hazard analyses and authored Risk Management Reports for remediated combination products
  • Provided risk management oversight for global medical device manufacturer of In Vitro diagnostic assays and assay instrument platforms under warning letter remediation effort, including the following activities:
    • Provided 483 remediation support activities in the area of risk management.
      • Mentored project teams during design change and risk documentation development following implementation of new risk management process.
      • Reviewed, red-lined, and approved over a thousand risk documents including design, process, and application FMEAs, risk assessments, risk management plans/reviews/reports, and system risk assessments in accordance with FDA obligated interim controls.
      • Authored training materials/assessment tests and conducted training on ISO 14971 and FMEA concept fundamentals and company’s new risk management process for over 40 engineers, quality assurance personnel, and management.
      • Named Global 3rd Party consultant on risk management, leading effort and setting FDA obligated interim controls.
      • Trained, mentored and certified internal resources at multiple global sites as Risk Managers/Specialists.
    • Provided 483 remediation support activities in the area of pre-market notification
      • Performed process mapping of design change and pre-market notification processes used to modify pre-market notification procedures.
      • Reviewed, red-lined, and approved new set of pre-market notification procedures and decision trees compliant to 21 CFR Part 807 Subpart E/809/814/860/862/864/866.
      • Reviewed, red-lined and approved training materials and assessment tests.
  • Managed various project activities for medical device manufacturer of products in critical care, diagnostics and interventional radiology, peripheral intervention, endoscopy and surgery, including the following activities:
    • Managed multiple project teams delivering implantable products (drug-eluding stent and balloon expandable stent) to clinical trial.
    • Performed research, design, and development of medical devices and their associated manufacturing processes including scale up to production.
    • Authored DHF and risk management files for various medical devices, such as a wire guide hemostasis device, catheter fixation device, stent delivery system, blunt force trauma device, and covered endovascular stent (user requirements, design input documents, multiple design output documents, drawings, etc.)
    • Performed/coordinated prototyping, characterization studies, biocompatibility studies, animal studies, verification and validation, and associated histology activities for drug-eluting stent delivery systems, blunt force trauma devices, and covered stent delivery systems.
    • Performed extensive research in the field of super-elastic metals (Nitinol), including tensile testing, differential scanning calorimetry (DSC), dynamic mechanical analysis (DMA), x-ray diffraction experiments, data acquisition, and analysis leading to innovative stent designs.
    • Co-authored formal design control and risk management procedures compliant to 21 CFR Part 820, ISO 13485, ISO 14971:2007 and EN ISO 14971:2012.
    • Audited and coordinated remediation of drug-eluting stent DHF.
    • Awarded 19 US patents and 1 international patent.
    • Authored engineer internship and engineer training programs.
  • Provided quality management system development support for medical device start-up company of new In Vitro diagnostic technology and instrument platform, including the following activities:
    • Developed risk management process compliant to ISO14971:2007 and EN ISO14971:2012 revolved around start-up company’s line of IVD products.
    • Authored multiple risk management procedures, work instructions, and risk documentation templates facilitating implementation of risk management process.
  • Provided industry training, including the following:
    • Risk management training at OrthoTec 2013, Warsaw Indiana to representatives from OEMS (such as Zimmer, Spinal Simplicity & DePuy) with a few suppliers (such as Arthrex Manufacturing, Plasticomp, and McMaster-Carr) with a mix of job titles ranging from director, QA/QC, and engineering titles.

PROFESSIONAL EXPERIENCE

  • Boston Scientific, Project Lead, Warning Letter Risk Management File Remediation – 1/2016 to 2/2017
  • Boston Scientific, Project Lead, Quantitative Risk Management Process Development – 4/2015 to 1/2016
  • Johnson & Johnson®, Project Lead, Design History File Remediation – 11/2013 to 7/2015
  • Rapid Diagnostek®, Risk Management consultant – 12/2012 to 5/2013
  • TDC Medical, Inc, Product Development consultant – 8/2012 to 8/2012
  • Beckman Coulter, Risk Management 3rd party consultant – 3/2011 to 9/2013
  • Cook Medical, Senior Development Engr. and Development Engr., Bloomington, IN – 8/2002 to 3/2011
  • Vermont Yankee Nuclear Power Corporation, Senior Regulatory Compliance Engineer and Shift Technical Advisor, Vernon, VT – 11/1997 to 8/2002
  • Department of Defense, Shift Test Engineer and Nuclear Engineer, Portmouth, NH – 10/1987 to 11/1997

EDUCATION

  • Bachelor of Science, Nuclear Engineering, UMASS at Lowell, Lowell Massachusetts – 9/79 to 5/84
  • Coursework in Electrophysiology and Biomedical Fluid Mechanics, Rose-Hulman Institute of Technology, Terre Haute, Indiana – 9/06 to 5/07

CERTIFICATION

  • Shift Test Engineer Certification, Portsmouth Naval Shipyard – 1992 to 1997
  • Shift Technical Advisor Certification – 1998 to 2002
  • Licensed Operator Certification – 1998 to 2002

TRAINING

  • Root Cause Analysis, Vermont Yankee Nuclear Power Corporation – 1997
  • Facilitating with Ease, Participative Dynamics – 1997
  • Total Quality Management, Conway Quality Systems – 12/00
  • Conflict Management, Conway Quality Systems – 12/00
  • Supervisory Training, Conway Quality Systems – 12/00
  • Human Performance, Vermont Yankee Nuclear Power Corporation – 1/01
  • ISO 13485
  • ISO 14971
  • Root Cause Analysis, Weaver Consulting – 5/05

AFFILIATIONS

  • ASME – American Society of Mechanical Engineers (Member # 000008104085) – 08/03 to Present

Ron Makar


Consultant


Dedicated, well-organized, professional with vast experience in medical device product development, quality management, quality assurance, and quality engineering, regulatory compliance, process and system engineering, manufacturing and supplier qualification. Multi-faceted with thirty-five years of experience in world-class medical device and biotech manufacturing operations. Professional background includes work experience in the areas of in vitro diagnostic medical devices, digital imaging equipment, interventional devices, bio-based materials, and bio-polymer devices and delivery systems.

CORE COMPETENCIES

  • Design Controls
  • Auditing (Lead, Process, Product, System)
  • Design and Development Planning
  • 21 CFR Parts 11/803/806/807/810/812/814/820
  • Design History Files/Device Master Records
  • ISO 9000 / 13485 / 14971
  • Risk Management / Hazard Analysis / FMEA
  • Council Directive 93/42/EEC
  • Critical-to-Customer / Critical-to-Quality
  • SOR/98-282/Canadian Regulations
  • Project Management
  • Training Programs
  • Process Development / Process Controls
  • Process Improvement/Six Sigma
  • Manufacturing SOPs / Work Instructions
  • Supplier Qualification
  • Process Validations (IQ/OQ/PQ)
  • Change Management/Change Controls

SELECTED ACCOMPLISHMENTS

  • Championed effort to direct and manage integration of risk management practices, compliant to ISO 14971:2012 (Medical devices: Application of risk management to medical devices), as Director, Quality Management, ActamaxTM Surgical Products LLC.
  • Led and managed failure modes and effects analysis (FMEA) for all product design aspects, e.g. user interface, performance, safety, efficacy, labeling and packaging,  for a two-part bio-polymer medical device product and delivery system (Source:  ActamaxTM Surgical Materials LLC, www.actamax.com), as well as process FMEA for critical contract manufacturing organizations.
  • Participated as member of 16-person FDA QSR consultant remediation team, led corrective action effort to bring into QSR compliance supplier and purchasing controls of international medical device company headquartered in Japan.
  • Provided guidance in the creation of a harmonized and simplified global product development and lifecycle management system of an international medical device company.  Worked with staff from 13 world-wide design centers to consolidate disparate systems into a common, global system.
  • Reviewed and approved design history files, device master records, device history files, change orders and design verification and validation protocols and reports for digital mammography hardware/software detector assemblies.
  • Established stage/phase gated product development process in accordance with U.S. CFR Title 21 Part 820, ISO 13485, and ISO 14971, MDD standards and regulations and business requirements, including:
    • Enabled development of two-part bio-polymer medical device product and delivery system (Source:  ActamaxTM Surgical Materials LLC, www.actamax.com).
    • Included all aspects of FDA QSR design and manufacturing control, including development of Design History File and Device Master Record.
  • Led quality assurance and quality management activities in development of several medical device and biotech products, including:
    • Worked on IVD blood chemistry analyzer systems, digital mammography detector assemblies, omega-3 enriched oil, and polytetrafluoroethylene (PTFE) coated stents.
    • Completed all product development activities with respect to FDA Quality System Regulation (QSR) and ISO 13485.
  • Designed and developed new product electronic circuitry and electro-mechanical subassemblies for in vitro diagnostic blood chemistry analyzer instrumentation.
  • Launched all-natural, all-vegetarian, and kosher (OU) Omega-3 dietary supplement as member of product team in role of Global Quality Manager.
  • Developed, established and integrated acceptable risk management processes in several quality management systems to ISO 14971.
  • Facilitated hazard analysis and risk analysis and risk evaluation activities with several medical device development operations.
  • Ensured that CMO had performed adequate and effective risk analysis of their manufacturing processes in partnerships with critical contract manufacturing operations.
  • Identified, investigated and resolved production problems for medical device production operation (blood chemistry analyzer systems).
  • Developed and implemented Statistical Process Control (SPC) analysis methods during final (finished) product testing of production of blood chemistry analyzer systems.
    • Allowed production organization to more accurately interpret and diagnose test result variation due to special causes vs. normal, inherent process variation.
    • Resulted in cycle time reduction and dollar savings in parts replacement.
  • Developed and implemented field service modification protocols.
  • Provided technical support, including product training, of medical device products to field service engineers and customers.
  • Developed meaningful and realizable specifications for various products manufactured by contract manufacturing operations utilizing process capability analysis.
  • Led efforts to validate Class 10,000 clean room in medical products development start-up facility.
  • Led business teams to obtain 3rd party certification to ISO 13485, as well as other ISO standards, such as ISO 9001 and ISO 9002.
  • Integrated Medical Device Directive (MDD) requirements (Annex II, Annex III and Annex V of EC-Directive 93/42/EEC of 14 June 1993) into business quality management system.
  • Assisted Regulatory Affairs Managers in review and management of regulatory submission data in role of Quality Assurance & Compliance Manager.
  • Managed internal auditing programs for several businesses.
  • Managed successful FDA inspection of medical device manufacturing operation.
  • Established and maintained several quality management systems to enable development and commercialization of medical device products compliant to U.S. FDA Quality System Regulation (U.S. CFR Title 21 Part 820), ISO 13485, and ISO 14971, Application of Risk Management to Medical Device.
  • Utilized Microsoft® SharePoint to implement and establish quality management system for ActamaxTM Surgical Materials LLC.
  • Identified and established mechanism with external service to manage documents (standards and regulations) of external origin.
  • Managed resolution of customer complaints with diverse business operations groups, including development and implementation of corrective and preventive actions.
  • Managed quality management system compliance of medical device manufacturer’s R&D division to ISO 9001, the FDA Quality System Regulation, and EN46001.
  • Developed and implemented product development and commercialization system compliant with FDA food (21 CFR Part 110) and dietary supplement (21 CFR Part 111) regulations.
  • Developed and presented several quality management system management reviews to company and business management in role of quality management system Management Representative.
  • Managed supplier qualification efforts of critical contract manufacturing operations (this involved obtaining assurance that selected critical suppliers were compliant to applicable FDA and ISO quality system regulations and requirements).
  • Managed efforts in development of quality agreements with critical suppliers.
  • Interfaced directly with critical contract manufacturing operations on regular basis to review, approve and release production lots.
  • Supervised production operation of twenty-five assemblers and technicians in production and quality control of blood chemistry analyzer systems.
  • Co-managed physical transfer of production operation (blood chemistry analyzer system) to area with 30% less space, resulting in improved production capacity and output.
  • Managed product, process and system audits, and non-conforming product failure analysis and product reliability testing activities in medical device production operation.
  • Responsible for release to market of FDA Class II finished medical device products (blood chemistry analyzer systems).
  • Led efforts to establish FDA QSR and ISO 13485 and 14971 complaint quality managements systems in several management systems.
  • Developed and provided hands-on continuous improvement training and guidance in areas of product development planning, process validation, control and reduction of product and process variability, and product change control.
  • Identified and implemented novel and effective way to present standard operating procedures using information mapping (www.informationmapping.com).
  • Managed and directed multi-disciplined team effort to implement pilot phase of corporate-wide Product Data Management (PDM) system (through this work, team was able to demonstrate product development and manufacturing cycle time reduction feasibility and annual manufacturing cost reduction of over $100,000).
  • Developed and maintained customer complaint and CAPA process for medical products business unit.
  • Championed effort to implement EtQ enterprise quality management system (www.etq.com), which was utilized for customer complaint handling and CAPA (resulted in more effective management of customer complaints, enabling co-located complaint management units to manage customer complaints in single system).
  • Developed and presented training session titled: The Value of ASQ Certification to corporate quality managers.

PROFESSIONAL EXPERIENCE

  • Innovative Quality Consulting, LLC, Owner and Principal Consultant (Wilmington, DE) – 3/15 to present
  • ActamaxTM Surgical Products LLC, Director, Quality Management (Wilmington, DE) – 12/11 to 1/15
  • E.I. DuPont de Nemours & Co., Inc., Global Quality Manager (Wilmington, DE) – 7/07 to 1/15
  • Hologic, Inc., Plant Quality Assurance Manager (Newark, DE) – 4/03 to 7/07
  • W.L. Gore & Associates, Inc., Quality Assurance Associate (Elkton, MD) – 4/01 to 2/03
  • Dade Behring Inc., Quality Assurance Manager (Newark, DE) – 1999 to 2000
  • Dade Behring Inc., Quality Assurance & Compliance Manager (Newark, DE) – 1996 to 1999
  • E.I. DuPont de Nemours & Co., Inc., QA & Compliance Manager (Newark, DE) – 1994 to 1996
  • E.I. DuPont de Nemours & Co., Inc., Product Quality Management Eng. (Newark, DE) – 1993 to 1993
  • E.I. DuPont de Nemours & Co., Inc., Production Supervisor (Newark, DE) – 1990 to 1992
  • E.I. DuPont de Nemours & Co., Inc., Product QA Supervisor (Newark, DE) – 1989 to 1990
  • E.I. DuPont de Nemours & Co., Inc., Process Engineer (Newark, DE) – 1987 to 1989
  • E.I. DuPont de Nemours & Co., Inc., Systems Support Engineer (Newark, DE) – 1984 to 1987
  • E.I. DuPont de Nemours & Co., Inc., Product Development Engineer (Newark, DE) – 1980 to 1984

EDUCATION

  • Master in Engineering (Biomedical Eng.), University of Virginia, Charlottesville, VA – 8/78 to 5/80
  • Bachelor of Science (Medical Technology), University of Bridgeport, Bridgeport, CT – 9/72 to 5/75
  • Associate in Science (Electrical Eng. Tech.), Norwalk State Tech. College, Norwalk, CT – 9/70 to 5/72

CERTIFICATION

  • Biomedical Auditing (CBA), American Society for Quality – 3/11 to Present
  • Hazard Analysis and Critical Control Points (CHA), American Society for Quality – 3/10 to Present
  • Mgr. of Quality/Organizational Excellence (CMQ/OE0), American Society for Quality – 3/98 to Present
  • Quality Auditing (CQA), American Society for Quality – 12/95 to Present
  • Quality Engineering (CQE), American Society for Quality – 6/94 to Present

TRAINING

  • ISO 13485:2016 Changes and Implementation Best Practices, ASQ Biomedical Division – 5/16
  • Minitab 17, Minitab Quality Trainer – 1/16
  • Six Sigma Green Belt Training, E.I. DuPont de Nemours & Co., Inc. – 10/08
  • Six Sigma Greenbelt Overview Series, American Society for Quality – 4/07
  • ISO 14971:2007 [Risk Mgt. for Medical Devices], Assoc. for the Advancement of Medical Instrumentation (AAMI) – 4/07
  • Understanding and Implementing the New ISO 13485:2003 Standard, EXCEL Partnership Inc. – 1/06
  • R&D Risk Management & FMEA, LOGICON – 11/00
  • Understanding Financial Business Management, SMG – 4/99
  • 21 CFR Part 11 – Electronic Records and Signatures, FDA – 1/99
  • Planning and Managing Projects, Integrated Project Systems – 3/98, 5/9
  • Understanding the New Medical Device GMP, Stat-A-Matrix – 10/96
  • Advanced Auditing Techniques: Process Auditing, Stat-A-Matrix – 1/96
  • Quality Engineering Course, CQE, Total Business Service Center, Inc. – 11/95
  • Quality Auditing Course, CQA, Total Business Service Center, Inc. – 6/94
  • Statistical Process Improvement Techniques for Process Validation, Logicon R&D – 6/94
  • Management Problems of the Technical Person in a Leadership Role, Fred Pryor Seminars – 3/94
  • Collaborative Problem Solving, DuPont Corporate Continuous Improvement Curriculum – 8/93
  • Train the Trainer, Fred Pryor Seminars – 9/92
  • On-The-Job Auditor Training, Batalas – 8/92
  • Product Quality Management System Tech., DuPont Quality Management & Training Center – 6/92
  • Lead Assessor Certification, Batalas – 8/92
  • Deming Philosophy, DuPont Medical Products – 12/89
  • Medical Device GMP’s and Regulations – Quality Program Preparation and Audit, Stat-A-Matrix – 11/89

AFFILIATIONS

  • American Society for Quality (ASQ), Senior Member (Member No. 00947837) – 1989 to Present
  • Project Management Institute, Member No. 4427883 – Member since January 2016

PUBLICATIONS AND PRESENTATIONS

  • Managing Product Risk from Cradle to Grave, ASQ World Conf. on Quality and Improvement – 5/14
  • How Healthy (Robust) is Your Ability to Manage Risk? Thoughts on Risk Based Thinking in ISO 9001:2015, Presented at the March 17, 2016 ASQ Delaware Section dinner meeting

Jonathan Malave


Consultant


Results-oriented, high-energy, hands-on professional, whose major strengths include effective leadership, adaptive skill sets, efficient communication, attention to detail, and dutiful respect for compliance in all regulated environments, with a successful record of accomplishments within the pharmaceutical and medical device industries. Experience in the development, manufacturing, and release of various immediate and controlled release dosage forms, such as tablet, capsule, topical, and suppository dosage forms, single and multiple active, proprietary combination, abuse-resistant, opioid, autoimmune disease, immune-mediated inflammatory disorder, immunosuppressive, antipsychotic, and anemia drug products, and medical device products.

 

CORE COMPETENCIES

  • Project Leadership / Project Management / Project Planning / Project Scheduling / Gantt Charts / Project Execution
  • Communication Planning / Project Risk Management / Issue Reporting / Stakeholder Reporting
  • Supply Chain Processes / Packaging Operations / Logistics Processes / Distribution Processes
  • Change Management / Corrective and Preventative Action / Design Control / Risk Management Planning / Risk Analysis
  • Controlled Temperature Shipping Solutions / Requirements Definitions / Thermal Equivalence / Technical Justifications
  • Controlled Temperature Shipping Qualifications / Package Material Testing / Packing Instructions / Bill of Materials
  • FDA 21 CFR Part 820 / FDA 21 CFR Part 210 / FDA 21 CFR Part 211 / FDA 21 CFR Part 11 / ISO 9000 / ISO 13485
  • Medical Device Directives (MDD 93/ 42EEC) /Canadian Medical Device Regulation / Drug Enforcement Agency Law
  • Process Verification / Process Qualification / Process Validation / Analytical Methods / USP Methods
  • Facility Validation / Manufacturing Equipment Validation / Analytical Equipment Validation
  • Root Cause Analysis / Nonconforming product Handling / Complaint Investigations / Medical Device Reporting
  • Site Investigations / Supplier Investigations / Laboratory Investigations / Deviation Handling
  • Internal Audits /External Audits / FDA Audits /ISO Audits / Vendor/Supplier Audits
  • Quality System Implementation / Procedural Development / Work Instructions / Training Programs
  • Labeling Issuance / Labeling Review / Labeling Approval / Labeling Control / Labeling Change Control
  • Document Control / Laboratory Notebook Control / Raw Data Handling /Batch Record Control
  • Annual Product Reviews / Product Annual Reporting for New Drug Applications/Abbreviated New Drug Applications
  • PDEA ARCOS Reports / Year End Reports / Controlled Substance Quota Requests
  • Certificates of Analysis (COA) / Certificates of Conformity (COC) / Certification/Recertification COA/COC
  • Environmental Monitoring / Air Particulate Monitoring /Viable Organism Monitoring / Water Monitoring
  • Analytical Instrumentation (HPLC / GC / UV / Dissolution I-III / AA / Viscometer)

SELECTED ACCOMPLISHMENTS

  • Led and managed global market transition initiative for multiple drug products, devices, and presentations to establish equivalency between new cold chain shipping solutions and previously qualified containers based upon leveraging justifications
  • Directed efforts to identify and implement cold chain shipping solutions with respect to various countries and markets based upon project schedule
  • Managed endeavors to confirm that project scope adequately defined, develop key event maps, and verify milestones for global harmonization project
  • Guided team to ensure proper communication of inter-company and affiliate concerns and requests with respect to controlled temperature shipping solutions
  • Facilitated global change control efforts to support ongoing market transition projects
  • Led and managed efforts to establish equivalency of gel pack components to support supplier change request being implemented as part of cost saving initiatives, coordinating efforts to conduct required material testing, tensile testing, qualification testing, and statistical analysis, necessary to transition from old to new components
  • Led initiative to reduce processing time for investigations, deviations, complaints, SOPs and validation documents to meet compliance and production requirements, thus resulting in an increase in on-time results from 50% to 96%
  • Managed effort to decrease cycle times for investigations, and their related corrective actions/preventative actions to meet current industry practices, thus resulting in an increase in on-time results from 70% to 95%
  • Led QA department in regulatory body and agency inspections in response to multiple FDA 483 deficiencies, along with ISO notifying body nonconformance’s
  • Drove 38+ CAPAs, and numerous nonconformances, to effective closure, with many associated with systemic deficiencies (stability failures/validation/sterilization/labeling/training/CAPA/nonconformance/internal audit/packaging)
  • Managed and brought into compliance corporate-wide label system project that included input/output process and flow-mapping of all label systems, including internal label request/production/issuance process, label review, and approval process, maintenance and management of all master label documentation, and protocol development, along with harmonization of all relevant off-site facilities
  • Directed staff consisting of Quality Engineers, DEA specialists, QA specialists, QA reviewers, and QC supervisors
  • Monitored contract manufacturers, packagers, laboratories, and component suppliers to insure ongoing regulatory compliance
  • Revised, approved, and issued master batch records to encompass entire operation, improving manufacturing time and efficiency
  • Established robust CAPA review, and materials management boards, within bi-weekly meetings to insure dissemination of status to all relevant management
  • Implemented and utilized root cause analysis/risk management tools to establish proper effectiveness checks within CAPA systems, along with development of failure mode/root cause coding system to more accurately identify negative trending as applied to quality metrics
  • Worked in concertion with international establishment to research and develop proprietary product, safely viable for human application, which turn a profit margin ranging from approximately 400% to 700%
  • Implemented health and safety policy, maintained insurance policy and tax filing, managed financial, marketing, sales-consultations program, internal documents development, technical operations management, and product research and development information and activities
  • Developed and maintained strong working affiliations with medical doctors and professionals in order to help resolve patient symptoms directly related to adverse biological afflictions (e.g. Lupus, Trichotillomania, Chemo/Radiation Therapies, Alopecia, etc.)
  • Developed and managed strong, lasting relationships with clientele and established a near zero turnaround ratio within customer base

PROFESSIONAL EXPERIENCE

  • Quality Solutions Now (QSN) (Emmaus, PA) – Consultant – 2011 to Present
  • Elite Pharmaceuticals (Northvale, NJ) – Manager, QA & Compliance – 2009 to 2011
  • Quality Solutions Now (QSN) (Bethlehem, PA) – Consultant – 2008 to 2009
  • IVRX Pharmaceutical Solutions (Springfield, NJ) – Manager, QA & Compliance – 2006 to 2008
  • A’jon IHD (Morristown, NJ) – President – 2004 to 2006
  • AAIPharma Services (North Brunswick, NJ) – Quality Assurance Specialist – 2001 to 2004
  • Warner-Lambert (Morris Plains, NJ) – R&D/Quality Design Chemist – 1998 to – 2001

EDUCATION

  • Bachelor of Science, Biology/Pre-Medicine, Monmouth University, West Long Branch, NJ – 1994-1998 (Pre-Medicine curriculum with multi-year acceptance into the University of Medicine and Dentistry of New Jersey (UMDNJ) summer medical school preceptorship program)

 

Paul J. Moran


Consultant


Management and technical professional with solid quality assurance, technical service, and compliance knowledge. Extensive experience with large multinational corporations, contract manufacturers, and small start-up companies in regulated environments within medical device, drug, drug-device combination product, and consumer product manufacturing industries. Background in implantable devices, surgical instruments, wound care products, plastics, adhesives, and Rx and OTC drug products.

CORE COMPETENCIES

  • Design Control/Design Changes Quality System Development/Procedures
  • Design Reviews/Design History Files 21CFR Parts 820/201/211
  • Material Specifications/Supplier Specifications ISO 9000/ISO 13485
  • Quality Engineering/Assurance/Control FDA Inspections/Remediation
  • Process Controls/Manufacturing Procedures Quality Audits/Gap Analysis
  • Process Validations/Process Capability Product/Process Audits/DHF Audits
  • Molding/Thermosets/Thermoplastics Product Recalls/Medical Device Reporting
  • Change Controls/Engineering Change Notices Establishment Registrations/Device Listings
  • Complaint Handling/CAPA FDA/ISO Training/Audit Training

SELECTED ACCOMPLISHMENTS

  • Provided consulting support and completed compliance activities for various medical device and drug manufacturers, including:
    • Wrote and managed approvals of various procedures relative to quality systems in drug and medical device locations.
    • Audited Class I-III devices, including drug-device combination, Rx, and OTC pharmaceutical manufacturing plants from multi-nationals to start-ups.
    • Developed full quality system for medical device start-up company.
    • Developed and completed design history files (DHFs).
    • Audited design control systems, making recommendations for DHF improvements.
    • Served on design control team providing guidance related to quality assurance.
    • Designed and conducted GMP training for plant floor and professional staff.
    • Managed calibration program for medical device company.
  • Coordinated quality objectives for medical device manufacturer of products in ostomy care, wound therapeutics, continence and critical care, and infusion devices, including:
    • Implemented procedures for compliance with 21CFR part 820.
    • Handled complaint and CAPA activities to facilitate investigations, identification of root cause and implementation of corrective and preventative actions.
    • Audited quality systems and developed global GxP audit program.
  • Managed various project initiatives for biotechnology manufacturer of drug products in neuropathology and autoimmunology, including:
    • Managed quality activities related to contract manufacturing of operations.
    • Maintained document control activities, including development of standard operating procedures (SOP), ensuring documents compliant with 21 CFR Part 210/211 regulations.
    • Handled complaints, addressing investigations, documentation of records, and corrective and preventative actions.
  • Facilitated numerous project efforts for high-profile drug, medical device, diagnostics, and consumer manufacturer of products in donor screening, immunohematology, clinical chemistry, immunodiagnostics, and wound care, including:
    • Wrote corporate quality policies, guidance documents, standard operating procedures, and work instructions for compliance with FDA and ISO regulations and guidance documents.
    • Conducted audits and provided compliance guidance to over 100 internal and contract locations related to pharmaceutical, Class I, II, and III medical device, combination product, diagnostics/biologics products.
    • Conducted pre-acquisition due diligence and/or post-acquisition quality system audits, reporting system issues to corporate and division management.
    • Developed training programs related to design controls, validation, complaint management, investigations, etc.
    • Wrote and edited global quality newsletter and FDA updates on key issues of compliance, auditing, training, and quality systems.
    • Completed Six Sigma Black Belt training and projects, and led Green Belt project personnel.
    • Led technical service personnel in quality engineering, quality improvement, complaint investigations and CAPA management.
    • Provided quality management support for scale-up location to include document approval, validation reviews, testing programs, and equipment review.
    • Managed technical service department in cost improvement projects for disposable devices.
    • Conducted product scale-up and manufacturing problem resolution in medical device plant.
  • Directed all quality assurance functions for manufacturer of $500 million consumer products division, with responsibility for 3 plants, 20 contract manufacturers and $3 million budget.
  • Developed new thermoset polymer products and resolved manufacturing and customer related problems for aerospace and electronic applications.
  • Researched new HPLC methods for drug and cancer laboratory within Yale Medical School.

PROFESSIONAL EXPERIENCE

  • Moran Consulting, Consultant, (Hopewell, NJ) – 2007 to Present
  • ConvaTec, Associate Director, Quality Assurance, (Skillman, NJ) – 2006 to 2007
  • Moran Consulting, Consultant, (Hopewell, NJ) – 2004 to 2006
  • Élan Pharmaceuticals Inc., Quality Assurance Manager, (Princeton, NJ) – 2003 to 2004
  • Ortho-Clinical Diagnostics, Manager of Regulatory Compliance (Raritan, NJ) – 2001 to 2003
  • Johnson & Johnson, Mgr, Tech. Assurance, Consumer Products (North Brunswick, NJ) – 1999 to 2001
  • Johnson & Johnson, Area Manager, Corporate Staff (New Brunswick, NJ) – 1990 to 1999
  • Boyle Midway (American Home Products), Director, Quality Assurance (Wayne, NJ) – 1988 to1990
  • Johnson & Johnson, QA Manager, Consumer Products (Skillman, NJ) – 1988 to 1988
  • Johnson & Johnson, Ntl. Technical Serv. Manager, Personal Products (Milltown, NJ) – 1984 to 1988
  • Johnson & Johnson, Group Leader, Technical Services (Chicago, IL) – 1978 to 1984
  • U.S. Polymeric, Research and QA Chemist (Stamford, CT) – 1973 to 1978
  • Yale Medical School, Research Chemist-HPLC (Newhaven, CT) – 1970 to 1973

EDUCATION

  • Studies towards Master in Business Administration, University of Bridgeport – 1973 to 1977
  • Bachelor of Arts in Chemistry, University of Connecticut – 1966 to 1969

CERTIFICATION

  • Certified Quality Auditor (CQA), American Society of Quality – Certified until 2006
  • Certified Quality Engineer (CQE), American Society of Quality – Certified until 2006
  • Certified Quality Manager (CQM), American Society of Quality – Certified until 2006

TRAINING

  • Auditing Clinical Trials/GCP, PTI International – 2004
  • Transition to ISO 9000, American Society of Quality – 2002
  • Bloodborne Pathogen Training, Ortho Clinical Diagnostics – 2002
  • Trackwise CAPA Training, Ortho Clinical Diagnostics – 2002
  • Finance for the Non-Financial Manager, Johnson & Johnson – 2000
  • Six-Sigma Black Belt Training, Johnson & Johnson – 1999
  • Microbiological Control and Compliance (Guest Lecturer), Ortho Pharmaceuticals – 1998
  • Signature of Quality (SOQ) Examiner (Malcolm Baldridge Criteria), Johnson & Johnson – 1997
  • FDA Training, Biometric Research Institute – 1996
  • Quality Systems in Pharmaceutical Industry (Guest Lecturer), Fairleigh Dickinson University – 1993
  • Certified Quality Auditor (Trainer), Johnson & Johnson – 1993
  • Lead Assessor Certification Training, Stat-A-Matrix – 1993
  • Aerosol Technology, Center for Professional Advancement – 1990
  • Action Tools for Middle Management, American Management Association – 1987
  • Implementing Juran (Quality Improvement), Juran Institute – 1987
  • Problem Analysis and Decision Making, Learning International – 1987
  • Quality Improvement Training, Johnson & Johnson Quality Institute – 1986

AFFILIATIONS

  • American Society for Quality (ASQ) – 1986 to 2006
  • American Chemical Society – 1969 to 2003

Linda Morgan


Consultant


Professional with technical and compliance knowledge, skilled in regulatory affairs, quality assurance, operations, and engineering. Highly credentialed with over thirty years of experience working for top global medical device manufacturers. Background in surgical stapling, sutures, point of care testing, orthopedic implants and human tissue.

 

CORE COMPETENCIES

  • 21 CFR Part 820/803
  • Operations Management
  • 510(k) Submittals
  • Six Sigma Training/Lean Manufacturing
  • Process Development/Process Controls
  • Project Management
  • Quality System Development/Support/Auditing
  • Operating Procedures/Work Instructions
  • Regulatory Affairs
  • ISO 9001/ISO13485/ISO14971
  • Corrective & Preventive Action
  • Process Improvement
  • Engineering Change Notices/Change Orders
  • Class II Medical Devices

SELECTED ACCOMPLISHMENTS

  • Development of a Quality System for medical device manufacturers of orthopaedic implants, including:
    • Wrote standard operating procedures and implemented the quality system and achieved ISO 13485 registration
    • Conducted management reviews and implemented quality metrics
    • Developed complaint management and tracking process
    • Conducted internal & vendor audits
    • Managed Material Review Board and CAPA processes to address nonconformance and address deficiencies in a timely manner
    • Managed contract manufacturers to achieve business goals through adherence to specification, quality agreements and on-site visits
    • Implemented risk management process, which also included post-market surveillance
    • Developed Quality System for two small start-up medical device companies
  • Facilitated and managed various projects for medical device manufacturers of products in orthopaedics and powered stapling devices, including:
    • 510(k) submissions coordination for multiple products, which all received clearance to market per 21 CFR Part 807
    • Completed establishment registrations, device listing according to 21CFR Part 807
    • Coordinated biocompatibility, toxicology, Eto residual, cleaning validation, sterilization and packaging validations in support of 510(k) submissions
    • Wrote protocols, supported testing and completion reports to support design verification and validation activities for sutures, surgical staplers, and orthopaedic devices in simulated bench top and cadaver testing
    • Achieved CE Mark for products through Technical File development and maintenance
    • Ensured Design History Files met the requirements of the regulations
  • Managed various projects in support of operations improvement for medical device manufacturer of suture products and point of care testing devices, including:
    • Served as project leader for manufacturing location and core team member for multi-site implementation for lean initiatives resulting in multi-million dollar savings for the company
    • Served as project leader for new product development launch
    • Conducted root-cause investigations
    • Developed and implemented Supplier Excellence Program, which included utilization of six-sigma tools leading to dock-to stock for multiple purchased components
    • Acted as project leader for root-cause investigation using the DMIAC process for a major point-of-care device, resulting in over $350K in annual savings
    • Qualified environmental monitoring system to maintain compliance to ISO standard Class 8
    • Managed procuring $20 million in raw material for chemicals and process components
    • Established and coordinated all training for the unionized Somerville Plant manufacturing operations
    • Supported development and approval of union contracts
    • Reduced cycle time for two departments by 20%
    • Implemented MRP Class A initiatives
    • Developed and implemented critical zone strategy for packaging suppliers, which included Control Plan and FMEAs
    • Ensured facility maintained regulatory compliance with respect to state, federal and international regulatory agencies FDA QSR, EN460001, ISO13485 and ISO9001
    • Utilized TrackWise for CAPAs, audits and non-conformances management

PROFESSIONAL EXPERIENCE

  • L C Morgan Consulting, Owner (Yardley, PA) – 5/10 to Present
  • Alku Technologies, Consultant (Andover, MA) – 10/12 to Present
  • Core Essence Orthopaedics, RA/QA Manager (Langhorne, Ft. Washington, PA), – 12/09 to 5/10
  • International Technidyne Corporation, Operations Director, (Edison, NJ) – 5/10 to 5/12
  • Power Medical Interventions, (Langhorne, PA), Operations/QA/Regulatory Management – 9/04 to 12/09
  • Johnson & Johnson Ethicon, Inc, Engineering and Operations Management, (Bridgewater, NJ and Cornelia, GA) – 9/89 to 9/04
  • Johnson & Johnson Ethicon, Inc, Engineering, (Bridgewater, NJ) – 9/79 to 9/04

EDUCATION

  • Masters of Business Administration, Marketing, University of Phoenix – 9/01 to 8/04
  • BSIE, New Jersey Institute of Technology – 9/76 to 12/81

CERTIFICATION

  • Logistics Certification – Georgia Institute of Technology
  • Six Sigma Green Belt Certified
  • Medical Device Certificate Program, RAPS

TRAINING

  • Quality Systems Regulations
  • Design of Experiments, Measurement Systems Analysis, Risk Management, STAT-A-MATRIX
  • ISO: 9000 and ISO: 13485 Internal Auditing, Power Medical Interventions and International Technidyne Corporation
  • Six-Sigma Black Belt trained, Green Belt Certified, Johnson & Johnson
  • Supply Base Management, Saddle Island Institute
  • Process Validation, Medical Design & Manufacturing Conference Training
  • Advanced Good Manufacturing Practices, Medical Design & Manufacturing Conference Training
  • Risk Management, Medical Design & Manufacturing Conference Training
  • Corrective and Preventive Action, Medical Design & Manufacturing Conference Training
  • Lean, Johnson & Johnson
  • Kaizen, Johnson & Johnson
  • 5S, Johnson & Johnson
  • Value Stream Mapping
  • Human Tissue Regulations, LifeCell™ Corporation

AFFILIATIONS

  • Regulatory Society Professional Society (RAPS)
  • American Society of Quality (ASQ)

 

Robin Norris


Consultant


Quality Management professional with extensive leadership experience in global organizations and broad background in quality management, regulatory affairs, quality systems, manufacturing, master production scheduling, supplier management and procurement, and research and development. Highly credentialed with years of experience in top global medical diagnostic manufacturers. Strong background in clinical diagnostic systems and services, with focus in clinical chemistry/immunochemistry, hematology, hemostasis, microbiology, urinalysis and diabetes products.

CORE COMPETENCIES

  • Quality System Development/Support/Auditing
  • FDA 21 CFR Parts 11/803/806/810/820/ISO 9000/ISO 13485/ISO 14971
  • Canadian Med Device Regulations SOR/98-282/European Union IVD Directive 98/79/EC
  • Change Initiatives/ Change Controls
  • Project Management
  • Operating Procedures/Work Instructions
  • Training/ Training Materials/Assessments
  • Process Improvement/ Lean Manufacturing

SELECTED ACCOMPLISHMENTS

  • Managed global Quality Management organization (RA/QA/QS/ Labeling) for in vitro diagnostic (IVD) Manufacturers of Chemistry/Immunochemistry, Hematology, Hemostasis, Microbiology, Molecular, Urinalysis and Diabetes products, including:
    • Maintained effective global QMS, compliant with regulatory, quality and business requirements.
    • Consulted with business Management (CEO, Heads of R&D, Manufacturing, Marketing, Finance) regarding quality policy, planning and operational targets/performance.
    • Ensured identification of critical business issues, prioritization of improvement projects, and reporting of selected KPIs.
    • Directed quality-focused projects to strengthen compliance, quality, cost-effectiveness and customer satisfaction.
    • Provided routine Quality Management support and guidance to R&D, Manufacturing, Marketing and Sales.
    • Interacted with global regulatory authorities, notified bodies and registrars.
  • Facilitated various manufacturing/supply chain change initiatives for IVD Manufacturers, including:
    • Supported transfer of reagent component and finished product manufacturing activities for specific product lines to alternate US and ex-US locations, including product revalidation, risk assessments, regulatory registrations, product labeling revision, training, quality control and quality system expansion.
    • Supported qualification of suppliers of key components and finished products, including quality plans, validation, verification, regulatory assessment and reporting, and documentation.
    • Supported transition to SAP in key reagent/instrument manufacturing sites and distribution centers, including quality plans, system and process validation, training, and documentation.
    • Supported development and implementation of packaging and global shipping temperature control requirements for IVD reagent products.
  • Led and managed numerous product quality and customer-focused initiatives, including:
    • Led cross-functional team (R&D, Manufacturing, Marketing, Quality) analysis of key IVD product quality issues for root cause identification. Resolution included specification revisions, raw material modification, supplier changes, and process control improvements. Concurrent 24% reduction of product quality issues during two-year timeframe.
    • Led multifunctional team (R&D, Manufacturing, Marketing, Quality) to develop/implement customer-focused metrics, consistent policy and process changes to improve customer satisfaction and trust. Improved customer on-line access to > 10,000 product documents.
    • Promoted employee quality awareness and focus through introduction of World Quality Day activities, Quarterly Quality Excellence Award, key customer interactions and implementation of strengthened quality system training for all employees.
    • Facilitated development and implementation of continuous improvement activities, including utilization of Lean/Kaizen events for Reagent & Instrument Manufacturing, Quality Management, Post-Market Surveillance, and Supplier Management processes.
  • Led multiple programs to strengthen regulatory and quality compliance, including:
    • Led consolidation of three independent acquired businesses into single global quality management system.
    • Implemented global processes and procedures for key business activities, including Quality Management, Reagent and Instrument Manufacturing, R&D, and Product Support.
    • Implemented business process changes to achieve compliance with new/revised quality/regulatory standards, including: FDA 21 CFR Part 11, Process and Software Validation, Risk Management and Regulatory Reporting.
    • Achieved ISO 13485 certification and coordinated Brazilian ANVISA certification across 12 manufacturing sites
    • Directed timely China registration of IVD products to maintain compliance with revised requirements.
    • Coordinated submission of R&D and Manufacturing documentation, China clinical evaluations, testing, interaction with China regulatory authorities, and product manufacturing/distribution strategy.

PROFESSIONAL EXPERIENCE

  • Siemens Healthcare Diagnostics, Global Vice President Quality Management (Newark DE) – 09//09 to 07/12
  • Siemens Healthcare Diagnostics, Vice President Quality Systems (Newark DE) – 11/07 to 08/09
  • Dade Behring, Inc., Vice President Regulatory Affairs/Quality Assurance/Quality Systems (Newark DE) -01/05 to 11/07
  • Dade Behring, Inc., Director/Manager Regulatory Affairs and Quality Systems (Newark DE) – 06/96 to 12/04
  • E.I. DuPont de Nemours & Company, Manager Manufacturing & Quality Assurance (Wilmington DE) -01/90 to 05/96
  • E.I. DuPont de Nemours & Company, Manager /Scientist positions in Reagent and Instrument Manufacturing, Technical Support, Master Production Scheduling, Supplier Management & Procurement, Research & Development, Training and Quality Assurance (Wilmington DE) – 06/76 to 12/89

EDUCATION

  • Bachelor of Science in Health Science (Medical Technology), University of Delaware, Newark DE

CERTIFICATION

  • Certified Medical Technologist, American Society of Clinical Pathologists (ASCP) – 07/75 to Present
  • Certified Lead Assessor, Batalas – 06/91
  • Certified Quality Auditor (CQA), American Society of Quality – 06/92 to Present
  • Certified Quality Manager (CQM), American Society of Quality – 03/99 to Present

AFFILIATIONS

  • Delaware Society for Clinical Laboratory Scientists (DSCLS); Member, Past-President and Board of Directors, 1976 – Present
  • American Society for Clinical Laboratory Scientists (ASCLS) Member, 1976 – Present
  • American Society for Quality (ASQ): Member, 1990 – Present
  • Regulatory Affairs Professional Society (RAPS): Member, 2004 – Present

Dario Olivera


Consultant


Professional with over 30 years of solid technical and compliance knowledge in manufacturing, operations, and technical management. Experience working in top global medical device, drug, biologics, and combination product manufacturing companies. Background in intraocular lenses, drug eluding stents, coated stents, ointments, capsules, tablets, crèmes, vitamins, nutritionals, diagnostics, veterinary injectables, cosmetics, etc.

 

CORE COMPETENCIES

  • Equipment Design and Selection
  • Product and Process Line Start-ups
  • Pharmaceutical Transfers and Start-ups
  • Medical Device Start-ups
  • Sterile Production and Sterilization
  • Clean Rooms
  • Aseptic Techniques
  • Commissioning and Decommissioning
  • 21 CFR Parts 4/210/211/820
  • ISO 13485/9001
  • Deviation and Change Controls
  • Project Management/Leadership
  • Re-Design Processes
  • New Product Transfers
  • Water Systems
  • FDA 483 Items
  • Warning Letter Remediation
  • Process Validation
  • Corrective and Preventative Action
  • Six Sigma and Process Excellence

SELECTED ACCOMPLISHMENTS

  • Project managed major combination drug/medical device manufacturer of new product, including:
    • Supported manufacture of drug-eluting stent.
    • Served as project management steering committee member as liaison and mentor to team in pharmaceutical regulations and compliance.
    • Addressed critical FDA 483 items and warning letter remediation process / activities.
    • Received considerable recognition for identification and resolution of business issues.
  • Project managed movement of operations for major North American pharmaceutical parenteral facility, including:
    • Moved injectable facility from Ft. Washington to new site.
    • Worked with R&D in development, scaled up and transferred new products including ESPREX, Alfenta, Sufenta, Haldol Dec, Haldol Injection, and Levaquin.
    • Managed budget in excess of $30MM and secured FDA approval.
    • Managed first approved biotech facility and product (Regranex Ointment) by CBER outside continental USA with $18MM project cost and secured FDA approval.
    • Directed operations (Pharmaceutical Products) and created new products support structure for management and engineering.
    • Supported activities in process transfers, facilities commissioning, validations, and startup of processes after FDA approval.
    • Provided leadership / liaison for startup of (coated stent) in San German.
    • Provided leadership to transfer of domestic and international (Europe, Mexico and Puerto Rico) high profile products.
    • Maintained business continuity (in addition to increased efficiencies) which was recognized as significant contribution resulting in formal corporate recognition.
  • Managed numerous projects for major pharmaceutical manufacturer responsible for all financial, regulatory, compliance, knowledge transfer, audit readiness and key technical activities, including:
    • Managed blow fill and seal process expansion from one line to 12.
    • Created 250 new jobs and met $35MM budget with FDA approval.
    • Managed cost reduction project to improve capsules and compression process.
    • Reduced nonvalue-added head count, replaced equipment and increased efficiency by more than 60%.
    • Closed facility in San Lorenzo Puerto Rico and transferred intraocular lenses operation process to new facility responsible for $20MM budget, receiving FDA approval.
    • Managed commissioning and validation of all processes with $32MM project scope (injectable, tablets, and crème).
    • Led over 600 associates focused on manufacture of pharmaceutical and ophthalmic products which included Eprex (erythropoietin), Levaquin, Reopro, Regranex, Leustatin, Alfenta, Cypher Stent).
  • Managed major pharmaceutical facility (infrastructure and facilities) that was not in production, but needed to be kept operational consisting of more than 400K square feet of area distributed in seven (7) buildings and 70 acres of land – Maintenance cost reduction assignment.
  • Performed remediation work for major multinational pharmaceutical company, including:
    • Reviewed and performed investigations related to complaints, deviations and change control, driven by previous FDA 483 observations and agreed actions with the agency.
    • Responsible for parallel project to develop a sustainable complaints investigations system.
    • Conducted fault tree analysis of manufacturing processes.
    • Mentored management towards an audit readiness process.
  • Completed 7 months readiness preparation for Dominican Republic medical device company for corporate audit and a remediation phase, including:
    • Focused readiness process towards building maintenance, preventive maintenance program and housekeeping, site training program, master validation, and site master plan.
    • Set up audit war room, audit rehearsals, and mentoring to SME.
    • Facilitated change controls review and updates, critical complaints investigations, CAPA needs and mentoring of the staff in the investigations approach from a regulatory and compliance perspective.
  • Managed and consulted for various projects for pharmaceutical and medical device manufacturers, including:
    • Provided consulting services as agent to foreign pharmaceutical company in Caracas, Venezuela coordinating and guiding their new product development.
    • Provided regulatory consulting for Puerto Rican pharmaceutical company manufacturing private label pharmaceuticals.
    • Provided regulatory consulting for product development of nutritional supplements for Miami based manufacturer.
    • Provided consulting support for outsourcing needs for German manufacturer of physiotherapy systems, innovative cardiology products, diagnostic products and software.
    • Designed and selected equipment for start-up new product/processes line and facility for pharmaceutical and medical device.
    • Led cross-functional team as operations director for new product transfers
    • Identified/implemented major process improvement to enhance product quality with automation and re-designed process.
    • Controlled sterile production (clean rooms, aseptic techniques, sterilization, water systems, purified water USP via mixed beds, reverse osmosis, distillation WFI, HVAC, product inspections of ampoules, vials, and devices).
    • Supervised validation department in all technical/validations activities at site.
  • Managed new products transfer, directed operations (Pharmaceutical Products) created new products support structure for management and engineering of major pharmaceutical manufacturer.
    • Products transferred to Puerto Rico were Eprex, Levaquin, Leustatin, Alfenta.
    • Responsible for the support activities in process transfers, facilities commissioning, validations and the startup of processes after FDA approval.
    • Provided leadership / liaison for the startup of (coated stent) in San German.
    • Provided leadership to transfer of domestic and international (Europe, Mexico and Puerto Rico) high profile products. Maintained business continuity (in addition to increased efficiencies) which was recognized by as a significant contribution resulting in formal corporate recognition.

PROFESSIONAL EXPERIENCE

  • Dario Olivera Consulting, Inc. President, (Mayaguez, Puerto Rico) – 2007 to Present
  • Cordis, LLC (Combo Products), Technical Transfer Manager – 2004 to 2007
  • Ortho McNeil Janssen Pharmaceuticals, Inc. Director Operations – 1987 to 2004
  • Cooper Labs / IOLAB (J&J), Inc. (Sterile Opthalmic), Operations Manager – 1982 to 1987
  • Merck, Process Head (Barceloneta, PR) – 1981 to 1982
  • Dade Diagnostics, Section Head (Aguada, PR.) – 1976 to 1981
  • Carter Pharmaceutical, Microbiologist (Rincon, PR) – 1975 to 1976

EDUCATION

  • Executive Education Program, Fuqua School of Business, Duke University – 1997
  • Bachelor of Science, Biology/Chemistry, University of Puerto Rico – 1972

CERTIFICATION

  • Project Management, ISPE – 2000
  • Process Excellence, J&J – 1999
  • Certified Quality Systems Trainer, J&J – 1995

Scott C. Otto


Consultant


Professional with over 33 years of extensive experience in package engineering. Experience working with high profile pharmaceutical and medical device manufacturers. Background in biologics, drug vials (glass and plastic), stoppers, seals, closures, catheters, cardiovascular and imaging products with various tubing sets (both pyrogenic and non-pyrogenic), electro-mechanical devices with various leads, sutures, absorbable implants, endoscopic instruments, cable driven instruments, orthopedic implants and instruments, specimen collection vessels and bags, surgical kits, absorbable dressing and anti-adhesion products, orthopedic implants, and instrument trays.

CORE COMPETENCIES

  • Project Management/Project Leadership
  • Research & Development/Package Engineering
  • Primary/Secondary/Tertiary Packaging
  • Controlled Temperature Shipping Systems
  • Packaging/Component Specifications
  • Thermoforming/Injection Molding
  • Extrusion Blow Molding/Blister Form
  • Vertical/Horizontal Form/Fill/Seal
  • Packaging Printing/Coatings/Sealing
  • ISTA/ASTM/ISO Test Methods and Standards
  • Test Method Validation/V&V Activities
  • Foam Materials/Fabrication
  • Sterilization/Aseptic Filling
  • Labeling/Graphics Design
  • 21 CFR Part 210 Part 211/Part 820
  • Six Sigma/Process Improvement/Lean Thinking

SELECTED ACCOMPLISHMENTS

  • Led development and validation of full-knee, uni-knee, hip and drug coated orthopedic implants, including low oxygen environment packaging, new carton supply sourcing project, orthopedic loaner kit design consulting and testing, packaging conversion-flexible to rigid development and validation, aging studies, sealing process development, procedures-global and site specific creation, sourcing (materials and services-testing, contract packaging, etc.), and root cause assessment for vial damage.
  • Led and executed 6 new product packaging development and validations, covering 140 SKUs, and 12 new product packaging development and validations, covering 1500 SKUs, including packaging conversion-flexible to rigid development and validation, aging studies, sealing process development, procedures, package redesign-size reduction, sourcing (materials and services), test equipment (I.D, acquisition, installation, validation, and procedures), and audit support.
  • Led fragility assessments, ISTA testing, cold chain package design and verification for biologic, 2-sealing process development and transfer, aging studies, USP moisture testing, induction seal equipment-materials-process, packaging operations assessment and production balancing, tooling designs and modifications, labeling process and systems assessment, postponement strategy (inventory and WIP reductions), procedure development, design control compliance and pilot, quick turn material shortage strategy and validation plan, development of return products assessment and salvage methodology, and mentoring Jr. engineers.
  • Completed feasibility phase for packaging on refresh project for $500MM segment of business with project objectives focused at design and cost improvements, including the following:
    • Established short and long term strategies.
    • Led packaging Sub-Team.
    • Developed new market unit design options and led selection process including total cost analysis identifying $500k-1MM in annual savings opportunities.
    • Integral to new labeling design and approach.
    • Key member of process sub-team team in establishing new packaging and manufacturing processes.
    • Key contributor to development and piloting of packaging elements for new design control process.
  • Managed new product packaging and technologies and existing product packaging design, development, and validation, including the following:
    • Implemented fragility and high-speed video analysis.
    • Implemented due diligence and design review processes.
    • Redesigned six existing packages due to recalls and/or customer complaints.
    • Participated in twelve new product launches.
    • Developed packaging design and processes as vehicle to facilitate antimicrobial agent deposition onto sutures.
    • Oversaw development, validation, and implementation of internally developed, global automated graphics creation, management, and printing system.
    • Reviewed custom kit assembler agreements.
    • Organized and co-led 2004 J&J World Wide Packaging Conference & PACE Awards.
    • Created and co-led J&J Cross Franchise Cold Chain Committee and conferences.
  • Led development and implementation of digital printing processes for folding cartons (second phase of digital print strategy) with savings opportunity of over $2MM annually, including the following:
  • Developed components and processes, thermoforms, form/fill/seal, sealing, printing, foams/cushioning, cartons, corrugated, labels, films, foils, Tyvek, seal coatings, sterilization, injection molding, and prototyping.
  • Led development, deployment, and administration of resources in partnership with multidisciplinary R&D teams for new product launches with over approximately 20 new products per year.
  • Mentored 2 engineers to management positions and 2 to sales positions.
  • Ensured compliance with regulations, such as ISO, QSRs, and MDD.
  • Supported sourcing consolidations and commensurate savings opportunities via use of new technologies, strategic partnerships, EOQ leveraging, and reverse auctions.
  • Supported licensing due diligence and integration.
  • 2001 member R&D tax credit team recapturing $13MM+ in missed credits.
  • Led J&J Signature of Quality (SOQ) Team responsible for critical support processes.
  • Integrated packaging development into R&D processes including Design Control.
  • Led packaging portion of design control revamp.
  • Developed packaging development procedures to support healthcare compliance and European supply chain management.
  • Led development, deployment, and administration of graphics resources to meet company objectives in alignment with regulations (ISO, QSRs, and MDD) and country specific national laws, including the following:
    • Served as operations strategy team member for development of 5-year plan/strategy.
    • Advised on framing of current Packaging organizational structure.
    • Determined how to meet and implement MDD requirements into product labeling.
    • Developed graphics systems, processes, and procedures where none existed (zero audit observations on first internal and ISO audits).
    • Implemented first multilingual packaging (7 languages) and coordinated associated activities with overseas affiliates (Marketing, Regulatory, and Distribution).
  • Managed concept, feasibility, design, development, and validation of packaging for sterile disposables, electronics and industrial accessories for new product launches (skin staplers, laser systems, harmonic scalpels, breast biopsy systems stands and cases, etc.), including the following:
    • Led Endoscopic Kit team (multidisciplinary, multi-site team business).
      • Grew business year on year from $15MM to $108MM in two years.
      • Developed new kit system, still unique to industry today.
      • Developed bulk packaging and requirements for custom kit assemblers.
    • Led medical packaging council technical and sourcing groups working on standardization of requirements and components supply supporting $100MM in corporate savings initiatives.
  • Led transfer of packaging operations from Somerville, New Jersey to Cincinnati, OH for equipment, tooling development and validations, on both manual and form/fill/seal processes, including the following:
    • Created and supported documentation, such as specifications, drawings, BOMs, procedures, and work instructions.
    • Conducted pre-release batch discrepancy reconciliation.
    • Installed and validated printing systems, such as lids stock, and labeling including implementation of bar coding.
  • Designed and developed sterile packaging for new products and served as technical support for existing product lines, including the following.
    • Resolved sealing issues at border operation in Mexico and lyophilization issues stemming from poorly formed tubing vials at suppliers.
    • Implemented packaging unitization analysis software.
    • Realized $700k in carton savings based on cost savings projects.
  • Assumed cradle to grave responsibilities for assigned product lines ranging from OTC to ethical/proprietary and generic pharmaceuticals for solid, liquid cream and ointment, and parenteral dosage forms.

PROFESSIONAL EXPERIENCE

  • Focus Packaging Solutions, LLC., Consultant, ( Doylestown, PA) – 2007 to Present
  • (Clients Supported: Zimmer (Multiple Divisions), Medrad, Pipeline Orthopedics & Biotechnology, BMS-Convatec, Pioneer Surgical, Covidien-Tyco Healthcare, Biomimetic, West Pharmaceutical Services, Hollowick, Argon Medical, Smith&Nephew, Hologic, Cirtec, Cambridge Endoscopic Devices, Apollo Endosurgery, Covidien Pharmaceuticals, Aprecia Pharmaceuticals, Brystol Meyers Squibb)
  • Ethicon Inc., Mgr/Principal Engr./Advanced Pkg. Dev. & Pkg Tech Svs. (Somerville, NJ) – 2003 to 2007
  • Ethicon Endo-Surgery, Inc., Manager, R&D Packaging (Cincinnati, Ohio) – 1995 to 2003
  • Ethicon Endo-Surgery, Inc., Section Manager Graphics (Cincinnati, Ohio) – 1994 to 1995
  • Ethicon Endo-Surgery, Inc., Staff Package Engineer, R&D (Cincinnati, Ohio) – 1991 to1994
  • Ethicon, Inc., Sr. Package Engineer, Operations (Cincinnati, Ohio) – 1990 to 1991
  • J&J Patient Care, Inc., Sr. Engineer/Staff Engineer (New Brunswick, NJ) – 1988 to 1990
  • Smith Kline Beckman, Sr. Packaging Engineer (Philadelphia, PA) – 1986 to 1988
  • International Paper Company, Can Shield Division, Sr. Package Engr. (Langhorne, PA) – 1983 to 1986
  • American Cyanamid, Lederle Labs, Pkg. Dev./Supply Supv./Line Supv. (Pearl River, NY) – 1980 to 1983

EDUCATION

  • Bachelor of Science, Packaging, Michigan State University, East Lansing, MI – 1980

CERTIFICATION

  • Process Excellence, Six Sigma Green Belt – 2002

PUBLICATIONS AND PRESENTATIONS AND PATENTS AND AWARDS

  • July Issue of Food & Drug Packaging (Cover) – 2004
  • November issue of Packaging Digest – 2004
  • Speaker-Health Pack 2001 on Six Sigma for Packaging – 2001
  • Medical Device and Diagnostic magazine – Ethicon Endo-Surgery Medical Packager of the Year – 1998
  • U.S. & International Patents on “Locking Holder for Pair of Syringes and Method of Use”, Johnson & Johnson Medical, Inc. (formerly Patient Care) – 1992
  • U.S. & International Patents on “Two Component Syringe Delivery System”, Johnson & Johnson, Medical, Inc. (formerly Patient Care) – 1990
  • IOPP Ameristar & Worldstar Awards for Thermoform Package Design – 2004
  • J&J Standards of Leadership Award for Management Support – 2004
  • J&J Standards of Leadership Award for Project Boxster – 2002
  • Recognition for R&D Tax Credit and J&J Signature of Quality initiatives – 2000
  • Ethicon Endo-Surgery, Inc.- Operations ‘Taking the Lead’ Peer Recognition Award for Packaging – 2000
  • Ethicon Endo-Surgery, Inc. – Presidents Quality Award for the COGS Review Process – 1998
  • Ethicon, Inc. Awards for Linear Cutter, Circular Stapler, Clip-Applier and Form/Fill/ Seal Projects – 1991
  • SmithKline & Beckman, Inc. – Vice President Impact Award for Pre-Natal Vitamin Print Prod. – 1987

Robert J. Serra


Consultant


Professional with strong scientific and technical expertise in chemistry, product development, quality assurance, and manufacturing. Experience working in major drug, biologics, and medical device corporations. Background in product development cycle from clinical through scale-up and commercialization for sterile potent and non-potent liquid products, sterile suspension products (parenterals and inhalation products), ophthalmic products, antibiotics, sterile biologic/device combination products, suture products, oral, polymeric compounds (polyglycolide and lactide), and solid dosage forms.

CORE COMPETENCIES

  • Design Controls/Design History Files
  • Package Material/Drop/Transportation
  • Testing Packaging Design/Controlled
  • Temperature Shipping SOPs/Work Instructions/Test Methods
  • Customer/Regulatory Requirements
  • Change Initiatives/Change Controls
  • Design Validations/Design Changes
  • Product Launches/Improvements/Transfers
  • Risk Management/FMEAs
  • Project Management
  • Process Controls/Development/Validations
  • Quality System Development/Support
  • Analytical Methods/Validations
  • Internal/External Audits
  • Equipment Installations/Qualifications
  • 21CFR Parts 210/211/820
  • Molding Manufacturing/Validations
  • ISO 9000
  • Packaging Validations/Seal Strength/Burst Testing
  • Process Improvement

SELECTED ACCOMPLISHMENTS

  • Consulted various manufacturers of pharmaceuticals, biologics, and medical devices for start-up companies and commercial manufacturing, including: ­
    • Provided technical support to regulated companies for start-up operations in global market ­
    • Conducted due diligence audits for potential acquisitions, partnerships, or research funding ­
    • Developed roadmap of activities from development through product commercialization ­
    • Developed documentations systems that include batch records, SOP’s, process specifications, product, and material specifications ­
    • Accessed current in-house capabilities and future needs based on project market forecast ­
    • Provided gap analysis to identify areas requiring support, documentation, and equipment ­
    • Provided technical assessment of current processes in terms of needed technical transfer/scale-up of development scale to commercial scale process ­
    • Provided assistance and direction for formulation and product development activities ­
    • Developed biocompatibility and product compatibility protocols to qualify elastomeric components, primary packaging components, and direct contact materials of construction with pharmaceutical and biologic drug products
  • Directed all activities regarding technology transfer, product, processes, and compliance for manufacturer of sterile potent and non-potent liquid products, including: ­
    • Provided master plan of documentation needed to support start-up operations ­
    • Developed device compatibility studies for disposable sterile bulk product transfer system ­
    • Provided technical input for facility, equipment, and process design ­
    • Designed chemical and microbiological labs and purchased equipment ­
    • Developed technology transfer documentation for product, process, and analytical transfers ­
    • Developed cleaning validation plan for multiuse facility ­
    • Reviewed and approved all validation documentation ­
    • Met with customers to review product and process information and recommended process changes where necessary ­
    • Performed internal and external compliance audits, and wrote documentation for procedures
  • Consulted various manufacturers of sterile and non-sterile pharmaceutical products regarding products, processes, and compliance, including: ­
    • Provided technical support to QA and operations in developing procedures, processes, and systems for start-up of commercial operations for drug/device combination product ­
    • Supported drug regulatory personnel on combination drug /device products regulations ­
    • Provided direction and support on technology transfer of products between facilities and at third party contractors ­
    • Provided technical assessment of processes, scale-up, engineering, and facility designs ­
    • Conducted process, due diligence, and cGMP audits of 3rd party pharmaceutical facilities
  • Assisted R&D in dosage form and process development of scale-up activities and supportive studies for drug manufacturer of sterile suspension product in phase II, including:
    • Managed new product transfers within parenterals facilities ­
    • Provided engineering process design and review for full scale commercial process ­
    • Developed studies to support process changes, terminal sterilization, and stability studies
  • Performed technical support and process improvements for major drug and biologics manufacturer of parenteral and ophthalmic products, including: ­
    • Conducted drug product compatibility studies for elastomeric materials of construction in direct contact with drug product ­
    • Developed and implemented plan for defining requirements for critical processing parameters to perform packaging ranging and validation studies ­
    • Developed compatibility and stability studies for existing and new products ­
    • Qualified new drug substances, excipients, and packaging components ­
    • Oversaw third party contractor sites for parenteral products in terms of process and systems audits, compliance, and technology transfer ­
    • Consulted in design of new $250 MM parenteral facility for production of therapeutic and cytotoxic compounds employing use of automatic filling, lyo loading/unloading systems, and isolation technology ­
    • Led significant Black Belt project team in pharma sector across multidisciplinary companies involving $7 MM COG’s project which resulted in annualized COG’s savings of $ 0.6 MM ­
    • Led task force for qualifying new primary flexible container by replacing current supply, upgrading, and revalidating sealing equipment, thereby eliminating major sealing rejects ­
    • Led task force for scale-up and transfer of antibiotic, which included qualification of film extrusion for flexible primary container, flexible container fabrication, terminal sterilization validation, stability, and process validation ­
    • Performed audits at third party contractors in support of PAS’s
  • Facilitated process/dosage form development and technical support for drug manufacturer of liquid products for clinical studies and commercial products, including: ­
    • Assisted in development of oral suspension product for phase III supplies and stability ­
    • Coordinated PAI activities and technology transfer of liquid products within domestic and international facilities ­
    • Facilitated process scale-up and validation of liquid and suspension products
  • Performed technical support and process/dosage form development activities for phase III and commercial for major manufacturer of parenteral drugs and biologics, including: ­
    • Performed process scale-up and validation of all products ­
    • Managed clinical batch production and audits of clinical records ­
    • Led successful PAI and on-time product launch for antibiotic at two 3rd party contractor sites ­
    • Served as liaison for preapproval FDA inspections and technical support
  • Managed various activities for major medical device, drug, and biologics manufacturer of parenterals and suture products, including: ­
    • Developed delivery systems for sterile biologic/device combination products ­
    • Developed low temperature terminal sterilization/tyndallization procedures for drugs/ biologics ­
    • Reviewed and wrote test procedures, specifications, CM&C section for N.D.A.’s ­
    • Implemented quality systems and procedures for new products ­
    • Developed and implemented quality systems for quality standards, documentation implementation, instrument deviation, and product complaints ­
    • Developed SOP’s, batch records, and product specifications ­
    • Assured that documentation, such as test procedures, test methods and specifications were developed, approved and implemented to support new products ­
    • Solved product or process problems for domestic and foreign affiliates ­
    • Developed tracking system for monitoring of clinical supplies inventories and studies ­
    • Conducted GMP training ­ Reviewed, dispositioned and released raw materials and finished products ­
    • Audited third party contractor facilities during clinical manufacturing for adherence to cGMP ­ Conducted periodic GMP, GLP, and GCP audits of laboratory areas, chemical processes, manufacturing areas and affiliated plants ­
    • Audited suppliers for cGMP compliance and recommended corrective measures ­
    • Planned and implemented manpower, expense, and capital budgets ­ Supervised process control activities and had statistical reports issued and corrective measures employed monthly to reduce possible rejections

PROFESSIONAL EXPERIENCE

  • Quantic Group, Principal Consultant (Livingston, NJ) – 2010 to 2012
  • QbD Auditing, Inc., Co-founder, Principal Consultant (Ormond Beach, FL) – 2009 to Present
  • Biopharma Consulting, Inc., Principle Consultant, (Ormond Beach, FL) – 2008 to Present
  • Isogen LLC, Vice President, Product Technology (Newark, DE) – 2007 to 2009
  • Biopharma Consulting LLC, Principal Consultant (Port Murray, NJ) – 2005 to 2011
  • Schering Plough, Global Mgr. Tech. Transfer, Parenterals/Inhalation Prod. (Cranford, NJ) – 2004 to 2005
  • OrthoBiotech/PSGA/Johnson & Johnson, Principle Scientist, Parenterals(Raritan, NJ) – 1999 to 2004
  • Novartis Pharmaceutical, Senior Scientist II, Liquids (East Hanover, NJ) – 1997 to 1999
  • RWJ Pharma. Res. Inst./Johnson & Johnson, Senior Scientist, Process Dev., (Raritan, NJ) – 1995 to 1997
  • BP Associated Consultants, Inc., President (Port Murray, NJ) – 1994 to 1995
  • Ethicon, Inc., Sr. Pharma Mfg. /Pharma. Mfg. Coordinator (Somerville, NJ) – 1990 to 1994
  • Ethicon, Inc., Product Coordinator (Somerville, NJ) – 1988 to 1990
  • Ethicon, Inc., Quality Assurance In-Process Sutures Manager (Somerville, NJ) – 1987 to 1988
  • Ethicon, Inc., New Products Coordinator/Assistant to Plant QA Manager (Somerville, NJ) – 1985 to 1987
  • Ethicon, Inc., Chem Lab Supv./Supv. In-Process QA/Supv. Mfg. QA (Somerville, NJ) – 1974 to 1985
  • MBH Chemical Corp, Manager Oral Products Department (Orange, NJ 07050) -1973 to 1974

EDUCATION

  • Associate in Applied Science, M.E. Technology, County College of Morris, Randolph, NJ – 2003
  • Master of Science (12 credits), Systems Engineering, Fairleigh Dickinson University, Teaneck, NJ – 1975
  • Bachelor of Science, Chemistry, Fairleigh Dickinson University, Teaneck, NJ – 1972
  • Military: Fort McClellan, AL, Chemical Defense Training Facility – 1971
  • Took highly accelerated 12 weeks of intense technical training performed by PhD’s administered in college setting. Training was equivalent to two full years of college level laboratory courses in Analytical Chemistry, Microbiology, and Radiological studies in order to perform duties as Mobile Analytical Laboratory.

MILITARY

  • US Army Reserves, 400th Chemical Caven Point NJ, Mobile Chemical, Biological, and Radiological Laboratory Operation (top secret classification) – 1970 to 1976
  • Teledyne Isotopes, Inc., Radioactive Sample Testing for U.S. Government Contracts (top secret classification) – 1968 – 1970

CERTIFICATION

  • ISO 9000 Lead Auditor Certification Program – 1994
  • Johnson & Johnson Certified Black Belt – 2002

PUBLICATIONS/PRESENTATIONS

  • Coauthor for chapter in text for Technology Transfer on Liquids
  • ISPE – Technology Transfer – Sterile Products
  • Novartis – Oral Suspension Interaction Resolution
  • Novartis – Preapproval Inspections Update
  • Arden House Technology Transfer Conference – Process Troubleshooting Case Study
  • Ethicon Research Conference – Hyaluronic Acid Formulation Process
  • Ethicon – In-vitro Test Method Improvement

AWARDS

  • Johnson & Johnson:
    • Innovation – Procedure improvement that reduced finished product rejects 30%
    • Pride – Process improvement for parenteral products
    • Team – Process and product improvement for a major suture defect
    • Team – Leustatin MS Project
    • Black Belt – Major reduction in pharmaceutical returns ($7MM annualized savings)
  • Novartis:
    • Oral suspension interaction resolution

Anthony “Tony” Simiele


Consultant


Experienced medical device professional with an accomplished 25+ year career of designing, launching, producing and supporting medical devices globally.  Have taken several Class II systems from concept through market end of life for Fortune 500 medical device companies.  Background in dialysis and apheresis systems, extracorporeal / patient access devices, RF ablation pain management systems and kits, surgical thermoregulatory management systems and vascular harvesting.

CORE COMPETENCIES

  • Design Control/Product Development
  • Design History Files/Design Changes
  • Design Verification/Design Validation
  • Process Controls/Process Validations
  • Corrective and Preventative Action
  • Problem Solving/ Fault Cause Analysis
  • Failure Investigations/Complaints
  • Change Controls/Change Initiatives
  • Post Market Initiatives/Medical Device Reporting
  • Risk Management/FMEA/Hazard Analysis
  • 21 CFR Parts 11/803/806/820
  • ISO 13485/ISO 14971
  • Portfolio/Project Management
  • Problem Solving Tools/Data Analysis

SELECTED ACCOMPLISHMENTS

  • Managed from concept through release new ISO 594-2 compliant access / administration kits for RF Ablation, managing all aspects of design controls.
  • Designed, launched and supported innovative medical instruments and disposable devices from concept through market end of life in the dialysis, RF ablation sectors and thermoregulatory markets.
  • Addressed FDA 483 and Warning Letter Observations; performed remediation activities for clients while under Consent Decree.
  • Led global cross functional teams in definition, prioritization, management and implementation of design changes and process improvements aligned with business objectives.
  • Concurrently managed and delivered programs for both internally and externally developed medical devices in the global dialysis, RF pain management and thermoregulatory markets.
  • Staffed and managed a team of 18 engineers that developed and performed over 30 subsystem design validations resulting in test reports that were key in obtaining a first pass FDA 510K approval of new Hemodialysis instrumentation system.
  • Managed over 20 CAPA and FCA compliance programs in the dialysis and thermoregulatory sectors from initial assessment through closure, presented programs and provided recommendations to senior management.
  • Staffed and led engineering team of 7 responsible for implementing design and process improvements that increased reliability, reduced defects and decreased product costs which resulted in increased sales in the dialysis market.
  • Led injection molded parts improvement program; revised tooling and supplier processes resulting in significantly improved reliability while decreasing costs.
  • Monitored system performance and customer satisfaction for multiple devices in global dialysis and thermoregulatory market. Reviewed complaints and trends, performed risk management reviews and managed appropriate remediation. Wrote technical summaries and MDR technical content.
  • Served as divisional Hemodialysis technical expert adept at analyzing complex system failures or product complaints to root cause, proficient at disseminating results to non-technical staff or customers.
  • Supported internal, external and FDA compliance audits.
  • Met with hundreds of dialysis customers globally as technical expert; obtained direct input from customers; created and presented customized technical sales presentations; formally presented products at international trade shows.
  • Planned and managed capital budget in support of process and design improvements.

PROFESSIONAL EXPERIENCE

  • Medical Device Solutions, Consultant – 2014 to 2015
  • Kimberly-Clark Corporation, Health Care R&D, Technical Leader – 2010 to 2013
  • Baxter Healthcare, Renal Division, Engineering Specialist (Senior Project Manager) – 2005 to 2009
  • Baxter Healthcare, Renal Division, Engineering Specialist (Project Manager) – 2001 to 2005
  • Baxter Healthcare, Renal Division, Senior Principal Engineer (Tech. Product Manager) – 1997 to 2001
  • Baxter Healthcare, Renal Division, Principal Engineer (Technical Product Manager) – 1996 to 1997
  • Baxter Healthcare, Renal Division, Senior Engineer – 1991 to 1996
  • Baxter Healthcare, Renal Division, Senior Product Design Engineer -1989 to 1991
  • Baxter Healthcare, Renal Division, Product Engineer – 1987 to 1989
  • Baxter Healthcare, Renal Division, Junior Product Engineer – 1986 to 1987

EDUCATION

  • Bachelor of Science, Electrical Engineering Technology, Northeastern University, Boston, MA – 6/1985

TRAINING

  • Requirements Management
  • Technical Writing
  • Project Management
  • ISO 13485
  • ISO 14971
  • PMP Exam Prep Course
  • DFMEA
  • Lead Investigator
  • TrackWise 7 & 8
  • DMAIC
  • Problem Solving / Critical Thinking
  • Injection Molded Medical Devices
  • CAPA
  • IEC 6060

AFFILIATIONS

  • Project Management Institute – 10/2013 to Present

PUBLICATIONS AND PRESENTATIONS

  • US Patent 20090198170 “Multi-pass dialysis” – August 6, 2009
  • US Patent 20090008306 “Extracorporeal dialysis ready peritoneal dialysis machine” – January 8, 2009