Medical Device Quality Management, Compliance, and Engineering Expert

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