President and Principal Consultant
Professional with solid technical and compliance knowledge, skilled in product development, quality engineering, and regulatory affairs. Highly credentialed with years of experience in top global medical device, biologics, and drug manufacturers. Background in orthopedic implant, safety needle/syringe, fluid therapy, clinical nutrition, patient monitoring system, infusion therapy, venous access systems, regional anesthesia, and wound drainage medical device, combination, and drug products.
- Design Controls/ DMADV/DFSS Methods
- Risk Management/FMEA/Hazard Analysis
- Process Development/Process Controls
- Operating Procedures/Work Instructions
- Inspection Procedures/Test Methods
- Sampling Techniques/Sampling Plans
- Project Management
- Quality Engineering/Regulatory Affairs
- Quality Control/Quality Assurance
- Change Initiatives/Change Controls
- Quality System Development/Support/Auditing
- Training/Training Materials/Assessments
- 21 CFR Parts 11/210/211/820
- ISO 9000/ISO 13485/ISO 14971
- Council Directive 93/42/EEC
- Process Improvement
- Six Sigma/Lean Manufacturing
Managed various project activities for medical device manufacturer of products in gastroenterology, urology, surgery, pulmonology, gynecology, and otolaryngology.
- Provided regulatory compliance support to R&D, Project Management, QA, Technical Writing, and Validation departments regarding design control activities in support of a web-based information management software solution, utilized to capture images and videos, and generate physician, nursing, and patient documents from captured data
- Conducted DHF audits and supported FDA and ISO audits.
- Supported risk management activities according to ISO 14971, including development of risk plans, completion of FMEA/hazard analysis, documentation of risk reassessment, implementation of process for verifying effectiveness of risk mitigations, and training.
- Prepared appropriate documentation required to support why FDA field actions not required.
- Conducted software validation of Excel-based risk assessment form, including preparation of user requirements, functional requirements, software risk analysis, and test cases.
- Completed gap analysis to identify compliance issues; developed quality plans to address issues and align/prioritize corrective actions required by numerous sources of external audits.
- Lead CAPA efforts to ensure implementation and closures according to schedules and tracking in CAPA database; developed supplier qualification and monitoring processes.
- Revised sampling plan, DHF audit, product development, risk management, validation, and GDP processes, including SOP’s, work instructions, process maps, and forms; developed training materials/assessment tests, and conducted training for over 50 team members.
Facilitated numerous project efforts for high-profile pharmaceutical, biologics, and medical device manufacturer of products in cardiology, dermatology, gastroenterology, immunology, mental health, nephrology, neurology, oncology, rheumatology, surgery, and virology.
- Led and managed Procurement, Package Engineering, QA Validation, and thermal qualification test laboratory team members responsible to evaluate replacement of old with new gel pack in various controlled temperature shipping systems; developed strategy for establishing equivalency based on statistical analysis of packaging material strength, puncture resistance, seal strength, and enthalpy, and worst case thermal testing, in place of full qualifications.
- Led and managed Package Engineering and QA Validation team members to requalify existing controlled temperature shipping systems and qualify controlled temperature shipping systems for new drug/biologics products, including development of project schedule, planning/scheduling of work, preparation of agendas, facilitation of meetings with thermal qualification test laboratories in UK, Harleysville, and Chicago, preparation of minutes to track action items, mitigation of risks to timelines, and reporting of progress and risks to upper management and product launch teams.
- Lead and managed Six Sigma team comprised of Package Engineering and QA Validation personnel to develop leveraging methodology using thermal mass, product weights, and specific heat to establish equivalency between previously qualified controlled temperature shipping systems for existing drug/biologics products and new products in place of full qualifications, which translated to $1M cost savings.
- Utilized leveraging methodology to prepare technical justifications, component specifications, packaging instructions, and bills of materials, providing rationale for use of existing qualified shippers with new drug, biologics, and combination device products.
- Completed gap assessment to identify compliance issues related to package engineering processes; developed schedule and lead team to address gaps; revised SOP’s, work instructions, and forms accordingly; coordinated associated training.
- Facilitated team comprised of domestic and international members, including Project Management, Package Engineering, Manufacturing Engineering, and Production personnel, to install and qualify toploading packaging solution from Dividella in Schaffhausen, and associated secondary packaging for vials, syringes, and injector pens; developed plan, scheduled and conducted meetings, updated plan, and prepared minutes to track action items.
- Facilitated team comprised of domestic and international members, including Project Management, R&D, QA, Package Engineering, Manufacturing Engineering, and Production personnel responsible for automation and secondary packaging technology required for processing and packaging prefilled glass syringes in Schaffhausan; maintained plan and prepared minutes to track action items.
- Managed global team responsible for establishing raw material qualification and vendor change control processes; utilized six sigma tools, including project charter, project plan, SIPOC analysis, process mapping, voice of customer at Leiden, Cork, Puerto Rico, Raritan, Springhouse, Malvern, Radnor, and Horsham sites, and database for tracking cycle times.
Conducted gap analysis for start-up implantable medical device manufacturer of products in spine, orthopedics, neuroscience, and vascular surgery seeking FDA compliance and ISO 13485 certification; managed consultant responsible for process validations related to manufacturing of proprietary gel technology; conducted due diligence investigation using fault tree analysis and prepared technical report to support complaint record.
Conducted gap analysis for prescription warehouse company intending to establish drug repackaging and manufacturing operations, and compliance with FDA 21CFR Parts 210/211.
Established complete quality system for medical device manufacturer of products that provide for vascular access and reduction of infection related to catheter related blood stream infections; quality system audited by FDA with no Form FDA 483 observations or warning letters.
Led and managed numerous project efforts for medical device manufacturer of products in fluid therapy, clinical nutrition, patient monitoring system, infusion therapy, venous access systems, regional anesthesia, and wound drainage medical device.
- Facilitated task reduction program to eliminate non-value-added inspection, reducing testing by 15%, and began transition of QC inspection to operator self-inspection.
- Conducted root cause investigations of nonconforming product, complaints, corrective action notifications, recalls, etc., resulting in annual reduction of nonconformances by 30%.
- Developed and implemented enhanced nonconformance system at 4 sites requiring methodical root cause investigations and implementation of corrective and preventative action based upon top 5 patient safety defects; improved deviation processes.
- Implemented start-up inspection for label printing and packaging operations, reducing nonconformances by 14% from previous year.
- Lead group in conducting daily MRB’s to expedite disposition of nonconforming material.
- Developed and implemented new material control program to reduce number of nonconformances related to mixed product internally by 68%; improved product identification and traceability program to enhance compliance; developed and implemented new label control program, ensuring that all labels were reviewed/ controlled prior to effectivity.
- Improved rework/reprocess system to better track activities for enhanced compliance.
- Facilitated major initiative between Quality, Manufacturing, and Engineering departments to create a harmonized classification of defects to better align categories with patient safety, functional, and cosmetic defects at 5 sites; developed and implemented improved inspection plans in packaging and molding, reducing inspection based on process controls/historical data.
- Implemented statistical charting programs (control charts and key performance indicators).
Managed various project activities for medical device manufacturer of needles and syringes.
- Provided QE support to R&D, Manufacturing Engineering, Production, QC, and QA for $93M product launch, specifically related to drawings, specifications, contract manufacturing, critical dimensions/tolerances, OGP Smartscope inspections, measurement methods, Gage R&R’s, validations, process capability, and facilities for manufacture of prototype and finished products.
- Managed team responsible for Six Sigma efforts, including implementation of customized reduced sampling plans leading to $200K annual savings and execution of verification trials for vision inspection systems leading to reduction in scrap of $50K annually.
- Managed internal and supplier audit programs; conducted audits; trained auditors.
- Reviewed water and environmental monitoring programs on monthly basis; managed investigations for failed test results; provided support for upgrade of DI/UF water systems.
- Conducted product impact investigations related to out-of-calibration nonconformances and prepared technical documentation to support impacts; conducted complaints investigations.
Facilitated various project efforts for medical device manufacturer of products in orthopedics.
- Completed establishment registrations according to 21CFR Part 807, device listings and premarket notification submissions, 510(k)’s, according to 21CFR Part 807, investigation device exemptions according to 21CFR Part 812, and premarket approval applications, PMA’s, according to 21CFR Part 814; coordinated biocompatibility studies, toxicology studies, and sterilization validations in support of 510(k) applications.
- Prepared test protocols, conducted testing, and completed test reports related to design verification testing of prototype and finished product bioabsorbable implants and sutures, polyester sutures, and titanium implants based upon simulated bench and cadaver testing.
- Quality Solutions Now, Inc., President (Emmaus, PA) – 10/04 to Present
- B. Braun Medical, QC/QE Manager (Allentown/Bethlehem/Breiningsville, PA/Cherryhill, NJ) – 1/04 to 4/05
- B. Braun Medical, QC Process Control Manager (Allentown, Bethlehem, and Breiningsville, PA) – 4/03 to 1/04
- Tyco/Healthcare/Kendall, Senior Quality Engineer (Deland, FL) – 1/02 to 4/03
- Tyco/Healthcare/Kendall, Quality Engineer (Deland, FL) – 3/01 to 1/02
- Arthrex, Inc., Regulatory Affairs Specialist (Naples, FL) – 6/99 to 3/01
- Naples Day Surgery, Quality Analyst (two Naples, FL sites) – 12/97 to 6/99
- Naples Day Surgery, Client Relations Representative (two Naples, FL sites) – 1/97 to 12/97
- Master of Science in Industrial Engineering, University of Miami, Coral Gables, FL – 9/95 to 12/98
- Master of Business Administration, University of Miami, Coral Gables, FL – 9/95 to 12/97
- Bachelor of Science, Aerospace Engineering, Florida Institute of Technology, Melbourne, FL – 9/86 to 12/90
- Certified Six Sigma Green Belt (CSSGB), American Society of Quality – 6/10
- Certified Quality Auditor (CQA), American Society of Quality – 12/02
- Certified Quality Engineer (CQE), American Society of Quality – 12/01
- Introduction to Medical Combination Products, Center for Professional Innovation & Education – 9/12 (1.4RU)
- Software Development for Medical Device Manufacturing, Software Quality Consulting – 11/10 (1.2 RU)
- Certified Six Sigma Green Belt Certification Preparation, American Society of Quality – 6/10 (3 RU)
- International Conference on ISO9000, American Society of Quality – 3/10 (1.8 RU)
- Understanding and Implementing the New ISO 13485 Standard, Excel Partnership, Inc. – 1/05 (1.4 RU)
- QSR for Medical Devices, Excel Partnership, Inc. – 8/03 (1.4 RU)
- Validation, Tyco/Healthcare/Kendall – 11/02 (2.4 RU)
- Sampling Techniques, Tyco/Healthcare/Kendall – 12/02 (0.8 RU)
- Lean Manufacturing, Colby Associates – 4/02 (4.0 RU)
- Behavioral Interviewing, Tyco/Healthcare/Kendall – 1/02
- Design of Experiments, Launsby Consulting – 7/01
- Team Building, Competitive Solutions, Inc. – 6/01
- Investigational Device Exemption, FDA – 12/00
- Internal Quality Auditing, Excel Partnership, Inc. – 12/00
- Major Testing Techniques for Plastics, ASTM – 12/00
- Advanced Failure Mode and Effects Analysis (FMEA) for Medical Devices, University of Wisconsin – 10/00
- E/M Testworks 3.0 (Material Testing Software), MTS Systems Corporation – 3/00
- Failure Mode and Effects Analysis (FMEA) for the Medical Device, University of Wisconsin – 1/00
- QSR for Medical Devices, Excel Partnership, Inc. – 10/99
- ISO 9000 Internal Quality Auditor, ISOtec – 6/98
- American Society of Quality (ASQ) (Member #01362884) – 7/00
- Healthcare Businesswomen’s Affiliation (HBA) (Member #9912470) – 10/12
- Regulatory Affairs Professionals Society (RAPS) (Member #09551147-0) – 10/12