Jose Ignacio Mora


Consultant


Professional consultant with solid technical and compliance knowledge with over thirty (30) years of hands-on expertise in the life sciences industry, specifically in medical device and pharmaceutical manufacturing. Background in surgical instruments, PTA and PTCA dilatation and guiding catheters, plastic surgery implants, tissue expanders, urology implants, urology devices, delivery systems for orthopedic implants, vascular surgery grafts and textiles, drug-delivery combination products, and pharmaceuticals.

CORE COMPETENCIES

  • Project Management
  • Combination Product Development
  • Re-Design Drug Delivery Products
  • Design Controls/Design History Files
  • Design Input/Output Traceability
  • Design Verification
  • Design Validation/Transfer
  • Process Validation (IQ, OQ, PQ)
  • Design and Process Controls
  • Design/Process/Application
  • FMEA Process Development
  • Technical Transfer
  • Facilities Transfer
  • KPI Reporting
  • Remediation
  • Risk Identification/Assessment
  • Risk Mitigation Effectiveness
  • Hazard Analysis
  • Fault Tree Analysis
  • SWOT Analysis
  • Root Cause Analysis
  • Numerous Statistical Analysis Techniques
  • CAPA Systems
  • FDA 21CFR Part 820
  • ISO 13485, 14971, 14644, 9000
  • ASTM F1585-00
  • Equipment/Tool Design
  • GD&T
  • Calibration/Metrology
  • Lean Manufacturing
  • JIT Inventory Systems
  • Kanban Systems

SELECTED ACCOMPLISHMENTS

  • Directed the manufacturing at startup urology products manufacturer, created, designed, implemented and led a world class medical device manufacturing operation for urology instruments and implants.
    • Increased gross margins by over 50% and substantially increased customer base.
    • Prepared manufacturing plan, visited suppliers, and successfully transferred the technology necessary to produce three different production lines inside a class 10,000 clean room (equivalent to an ISO 7 cleanroom)
    • Designed entire facility, supervised construction, hired staff, and created entire supply chain and manufacturing operation
    • Plant passed both FDA and ISO inspections
  • Acted as Combination Product Development Process (CPDP) leader for re-design of major drug-delivery combination product due to complaints and FDA involvement, guiding new design through various stages of design controls, including development of design and development plan, user requirement specifications, technical design requirements, design input / design output traceability matrix, design verification plan, design validation plan, and design transfer plan
  • Designed traceability matrix allowing clear tracking from design inputs through design transfer, utilizing unique identifiers that integrated with FMEA and other design control documents
  • Led and managed metrology sub-project, including execution of test method validation for multi-cavity injection molding scale-up of combination medical device / biotechnology product having fourteen (14) complex molded components, using eight (8) and sixteen (16) cavities each
  • Utilized problem-solving tools, DOEs, and statistical methods to troubleshoot discrepancies found with tooling and fixtures, as well as metrology methods, in order to resolve issues and establish equivalency between domestic and international metrology houses
  • Led and managed design verification test protocol and execution for drug-delivery combination system to assess risk related to shipping, transportation, and packaging, thus mitigating risk to patient due to improper drug product storage and handling conditions
  • Managed design review actions for drug-delivery combination system, driving successful closure of all open issues implemented to mitigate risk related to product design and compliance, thus ensuring that all corrective and preventive actions addressed
  • Reviewed and updated gaps in product and process FMEAs to address open items in design control of drug-delivery combination system
  • Managed CAPA and associated design verification test protocol to measure glide velocity of filled syringe assembly and mitigate risk of improper dosage to patient
  • Led, managed, and implemented cleaning and surface treatment process validation for spinal orthopedics component manufacturer, and established complete Design History File, including design and development plan, process FMEA, design inputs, design outputs, traceability matrix, design verification, while also meeting applicable ASTM standards for electro-polishing, anodizing, passivation, laser-marking, and associated cleaning processes
  • Identified potential risk of hazardous materials and contaminants in well-water during risk assessment at spinal orthopedics component manufacturer, detected presence of hazardous materials, and implemented risk mitigation to upgrade water purification and treatment for cleaning process rinse water, involving use of certified state labs to confirm successful removal of ground-water chemical contaminants
  • Designed and developed lean quality management system and controlled document system for start-up company involved in design, manufacture, and distribution of inhalers and asthma products for infants and adults
  • Developed templates for design inputs/design outputs traceability matrix, design verification, and design validation, providing unique identifiers traceable to design FMEA at start-up manufacturer
  • Created SOPs, preventive maintenance procedures, schedules, and training for operators for compliance with 21 CFR Part 820 and ISO 13485 with respect to surface treatment processes for spinal orthopedics component manufacturer
  • Developed and implemented portions of quality system and required bilingual documentation at orthopedic brace and wound care manufacturer necessary to transfer manufacturing from Florida to Mexico, ensuring that new workforce could manufacture safe products to meet 21 CFR Part 820 requirements
  • Configured Pilgrim SmartAudit system for molecular diagnostics company, incorporating requirements of 21 CFR Part 820 and ISO 13485 into audit elements
  • Led, designed, and implemented lean transformation of three major tablet and capsule production lines at top 20 pharmaceutical manufacturer, requiring thorough knowledge of regulations and traceability to ensure that process integrity was maintained following lean implementation
  • Managed, facilitated, and conducted cleanroom validation to ISO 14644 and ISO 14698 standards at contract component manufacturer, including risk assessment and risk mitigations associated with cleanroom utilities, facilities, practices, and supplies to prevent possible contamination of implantable, and invasive medical device components and coated guide wires
  • Designed, installed, implemented, and validated turnkey system for cleaning and disinfection of loaner surgical instruments, including process FMEA and DOE to optimize process settings
  • Conducted gauge R&R study for computerized test blood pressure, EKG, and other critical diagnostic and patient monitoring equipment
  • Conducted header bag process and sterilization validation, utilizing DOEs to establish robust seal process parameters at surgical kits manufacturer
  • Completed design of Device Master Record system, allowing company to close approximately 1,000 documented non-conformances throughout its product and manufacturing processes at brachytherapy catheter manufacturer
  • Configured and validated Pilgrim SmartSolve suite (SmartCAPA, SmartComplaints, and SmartAudit), including transition from paper to web-based CAPA system for fully-integrated functionality with document control, complaint management, and audit systems, also incorporating and configuring Six Sigma DMAIC process into SmartCAPA system at biotechnology manufacturer
  • Conducted validation of SmartDocs, SmartCAPA, SmartComplaints, and SmartAudit software at pharmaceutical manufacturer
  • Redesigned and rewrote process validation and CAPA system procedures for major orthopedics manufacturer in order to bring system into compliance with international standards and guidance documents, participating with counterparts in France and Ireland, to achieve division-wide standard system
  • Led emergency problem-solving task force to find root cause of orthopedic implant fracture, which resulted in patient injuries, leading investigation in France, conducting DOEs, utilizing Kepner-Tregoe® Problem Analysis, and successfully pinpointing cause of failure
  • Detected root causes of rust in knee instruments, as well as determined casting failure root cause, utilizing Kepner-Tregoe® Problem Analysis
  • Led investigation to determine root cause of contamination in product involving three facilities (New Jersey, Cork, and Limerick), successfully conducting DOEs and determining source of problem

PROFESSIONAL EXPERIENCE

  • Atzari Consulting LLC, Principle Consultant ( Pompton Lakes, NJ) – 2000 to Present
  • Boston Scientific, Director of Manufacturing Engineering (Wayne, NY) – 2003 to 2005
  • Stryker Orthopedics, Operations Quality Manager/Quality Systems Mgr (Allendale/Mahwah, NJ) – 2001 to 2003
  • UroSurge, Director of Manufacturing (Coralville, Iowa) – 1997 to 2000
  • Mentor, Engineering Manager (Irving, TX) – 1995 to 997
  • Cordis Corporation, Manufacturing Engineering Manager (Miami Lakes, FL) – 1992 to 1995
  • Cordis Corporation, Maintenance and Facilities Manager (Miami Lakes, FL) – 1989 to 1992
  • Cordis Corporation, Senior Manufacturing Engineer (Miami Lakes, FL) – 1985 to 1989

EDUCATION

  • Bachelor of Science, Mechanical Technology, Purdue University – 1980

TRAINING

  • Establishing a Dynamic, Effective Calibration Program: Calibration Fundamentals & Best Practices Seminar, Blue Mountain Quality Resources and The Lighthouse Training Group – 9/02 (≈ 1.6 CEUs)
  • Process FMEA Training, Mentor H/S – 3/96 (1.8 CEUs) DOE: Taguchi Techniques for Quality Engineering, Mentor H/S – 3/96 (≈ 2.4 CEUs) Process Validation, Mentor H/S – 2/96 (1.8 CEUs)
  • Fundamentals of Plastics, Commercial Polymer Materials, University of Massachusetts Lowell – 5/95 (2.25 CEUs) Introduction to Plastics, North Carolina State University – 10/93 (≈ 1.6 CEUs)
  • Custom Molding of Medical Plastic Devices, Society of Manufacturing Engineering – 12/92 (≈ 1.6 CEUs) Planning and Scheduling for Maintenance Operations, North Carolina State University – 12/88 (≈ 1.6 CEUs)
  • Design & Analysis of Experiments, Cordis Corporation – 3/86

PUBLICATIONS AND PRESENTATIONS

  • Design Control / Risk Assessment Training, Jerome Industries – 2/11 and 3/11
  • Workshop on Master Validation Plan, Informa Life Sciences, Cologne, Germany – 12/08
  • Using the Power of Computers for Process or Software Validation, Informa Life Sciences, Cologne, Germany – 12/08
  • Theory and Principles of Lean Documents, Design History File, Compliance on Line, Hyderabad, India – 6/07