Medical Device Quality Management, Compliance, and Engineering Expert

Technical Consultant #2088


Expertise

  • Medical device and biomedical industry planning, Integration, and organizational improvements, increasing financial performances for U.S. and European businesses.
  • Aligning technology and business strategy, medical device quality management regulations and requirements into effective and useful management systems.
  • Remedial quality management system compliance.
  • Pre-certification and internal auditing, including facilitation of third party registration activities.
  • Pre-FDA inspection readiness audits and gap analysis.
  • Auditing: Lead, processes, products and systems.
  • Change management.
  • Design controls.
  • Design and development planning.
  • Manufacturing SOPs and work instructions.
  • Process development and process controls.
  • Project management.
  • Process validations Installation Qualification, Operational Qualification, and Performance Qualification, (IQ, OQ, and PQ).
  • Product development and commercialization.
  • Quality engineering, Quality Control and Quality Assurance (QC / QA).
  • Quality management, Quality Management Systems (QMS) certification.
  • Risk management, hazard analysis and FMEA.
  • Six Sigma
  • Supplier qualification and Supplier quality assurance.
  • Council Directive 93/42/ EEC - (The European Economic Community)
  • ISO 9000 / 13485 and 14971.
  • 21 CFR Parts 11/803/806/807/810/812/814/820

Experience

Undisclosed Company, Principal, Present

  • Providing solutions to tomorrow's problems today for the medical device and biotech industries.
  • Remedial quality management system compliance activities.
  • Integration of business, U.S. and European medical device quality management regulations and requirements into effective and useful management systems (start-up ventures and established organizations).
  • Pre-certification and internal auditing, including facilitation of 3rd party registration activities.
  • Pre-FDA inspection readiness audits and gap analysis.
  • Establishing business-friendly product development and risk management systems.

Actamax Surgical Materials, LLD, Wilmington, DE, Director, Quality Management, 2012 - 2015

  • For a 50/50 joint venture, (between DuPont and DSM Biomedical): Managed the creation and effective establishment of the business quality management system, for successful development of an adhesion barrier (Class II) medical device.
  • Supported this business in this role in addition to fulfilling responsibilities as Global Quality Manager, DuPont, Industrial Biosciences.
  • Led effort to develop the business and quality management system to comply with FDA Quality System Regulation (QSR, 21 CFR Part 820), ISO 13485:2012, ISO 14971:2012, and business requirements.
  • Achieved third party certification and registration of the quality management systems to ISO 13485:2012, Medical Device Quality System Requirements.
  • Integrated ISO 14971: Application of risk management to medical device, into the quality management system.
  • Led quality management efforts to integrate Medical Device Directive (MDD) requirements (Annex II, Annex III and Annex V of the EC-Directive 93/42/EEC) into the business quality management system.
  • Led efforts to qualify critical contract manufacturing organizations (CMOs) and to integrate control of these CMOs into the quality management system.
  • Drafting and executing quality agreements with selected critical suppliers, performing qualification audits of supplier quality management systems, and ensuring that inputs to and outputs from these suppliers met business requirements.
  • Established a stage and phase gated product development process in accordance with U.S. CFR Title 21 Part 820, ISO 13485:2013, ISO 14971:2012, MDD standards and regulations and business requirements.

E.I. DuPont de Nemours and Company, Inc.,Wilmington, DE, 1980 - 2015

Global Quality Manager 2007 - 2015

  • Led product quality and quality management system efforts in the development of new medical device and biotech products.
  • Established business processes to facilitate the selection, qualification and support of critical contract manufacturing organizations (CMOs).
  • Supported the Actamax Surgical Materials, LLC, joint venture, in the role of Director, Quality Management.
  • Led quality management efforts resulting in business launch of an all-natural, all vegetarian, kosher (OU), Omega-3 dietary supplement.
  • Developed and implemented a product development and commercialization system compliant with FDA food (21 CFR Part 110) and dietary supplement (21 CFR Part 111) regulations.
  • Championed effort to implement EtQ enterprise quality management system through a web page to manage customer complaints and corrective and preventive actions among world-wide manufacturing groups.

Quality Assurance and Compliance Manager, 1994 - 1996

  • Developed and provided hands-on continuous improvement training and guidance in the areas of product development planning, process validation, control and reduction of product and process variability, and product change control.
  • Maintained and supported FDA Quality System Regulation compliance with Medical Products business units, including working with third party registrars and FDA.
  • Managed resolution of medical device complaints with diverse business operations groups, including development and implementation of effective corrective and preventive actions.

Product Quality Management Engineer, 1993

  • Managed the implementation of DuPont Product Quality Management (PQM) methodology in a manufacturing environment.
  • Coordinated, implemented, facilitated and trained continuous improvement activities for instrument manufacturing operations group.

Production Supervisor, 1990 - 1992

  • Developed Statistical Process Control (SPC) analysis in the final chemistry test phase of instrument production.
  • Implemented ISO 9002 quality management system.
  • Supervised a production staff of 25 technicians and operators in the production and quality control of DuPont aca┬« IV blood chemistry analyzer.
  • Co-managed the transfer of a production operation from one location to another, with 33% less space, resulting in increased capacity and production output.

Product Quality Assurance Supervisor,1989

  • Responsible for the release to market of FDA Class II finished medical devices (blood chemistry analyzers).
  • Managed product, process and system audits, non-conforming product failure analysis and product reliability testing.

Process Engineer, 1987 - 1989

  • Identified and resolved blood chemistry analyzer systems production problems.
  • Performed root cause analysis and implemented preventive action measures.
  • Utilized SPC techniques to identify and control production process variation.

Systems Support Engineer, 1984 - 1987

  • Developed and implemented field service modification protocols.
  • Provided product technical support to field service engineers and customers.

Development Engineer, 1980 - 1984

  • Designed and developed new product electronic circuit board and electro-mechanical subassemblies for in-vitro diagnostic blood chemistry analyzer instrumentation.
  • Managed field trials of prototype development products

Hologic, Inc., Wilmington, DE, Plant Quality Assurance Manager, 2002 - 2007

  • Provided FDA regulatory and ISO quality management systems guidance and support to the manufacturing organization, ensuring effective production and release of digital mammography detector assemblies (Class II medical device).
  • Managed successful revision of the operations quality and business management system to ISO 13485:2003 and ISO 14971:2000.
  • Led and directed management activities during a successful (no 483's recorded), routine FDA inspection.

W.L. Gore & Associates, Inc., Elkton, MD, Quality Assurance Associate, 2001 - 2003

  • Facilitated design control and product development activities for a Class III medical device (PTFE coated stent).
  • Implemented a Quality Management System (QMS) at a new start-up facility, to comply with FDA Quality System Regulation (QSR) and ISO 13485.

Dade Behring, Inc., Newark, DE, 1996 - 2000,

Quality Assurance Manager (Research and Development), 1999 - 2000

  • As formerly; DuPont Medical Products, Diagnostics Division, directed research and development quality management system compliance to ISO 9001:1994, the FDA Quality System Regulation, and EN46001.
  • Implemented information mapping improvement project resulting in more effective process SOPs.
  • Managed multi-disciplined team effort to implement pilot phase of corporate-wide product data management system.
  • Demonstrated product development and manufacturing cycle time reduction feasibility and annual manufacturing cost reduction of over $100,000.
  • Managed research and development QMS corrective and preventive action system and internal assessment program.

Quality Assurance and Compliance Manager, 1996 - 1999

  • Developed and provided hands-on continuous improvement training and guidance in the areas of product development planning, process validation, control and reduction of product and process variability, and product change control.
  • Maintained and supported FDA Quality System Regulation compliance with medical products business units, including working with third party registrars and FDA.
  • Managed resolution of medical device complaints with diverse business operations groups, including development and implementation of corrective and preventive actions.

Honors & Publications

Credentials

  • Professional Certifications (American Society for Quality)

Certifications:

  • Biomedical Auditor (CBA)
  • Hazard Analysis and Critical Control Point: (HACCP) AUDITOR (CHA)
  • Manager of Quality and Organizational Excellence: (CMQ/OE)
  • Quality Auditor (CQA)
  • Quality Engineer (CQE)

Academic and Professional Affiliations

  • American Society for Quality Training - ASQ (Senior Member)

Publications

  • For ASQ World Conference on Quality and Improvement.

Education

  • M.E. Biomedical Engineering, University of Virginia, Charlottesville, VA
  • B.S. Medical Technology, University of Bridgeport, Bridgeport, CT
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