Quality. Compliance. Success

Helping medical device companies leverage the value of their quality efforts,  reduce costs up to 20%, accelerate time to market by 25%, and control compliance risks.

Quality Management Professional

Dedicated, well-organized, quality professional with expertise in quality engineering, assurance, control and management as well as product development and commercialization, post-market technical support, regulatory compliance and production management. Multi-faceted with experience in world-class medical device and biotech manufacturing operations.

Extensive background in vitro diagnostic medical devices, digital imaging equipment, neurostimulation devices, interventional devices, bio-based materials, and bio-polymer devices and delivery systems.

  • Quality System Development
  • Regulatory Compliance
  • Product Development & Design
  • Quality Engineering Capabilities
  • Risk Management Integration
  • Supply Chain Management

Professional Experience

Consultant to domestic and foreign entities in the core arenas of quality, compliance, medical device, product review, regulation/requirement integration, and risk management.

  • Independent Contractor.
  • Lead Auditor (medical devices).
  • DEKRA Business Assurance (www.dekra.com).
  • FDA remedial quality management system compliance activities, post-market surveillance activities, product complaint reviews, and Medical Device QMS assessments.
  • Integration of business, U.S. and European medical device quality management regulations and requirements into effective management systems.
  • 3rd party registration activities to ISO 13485:2016, ISO 14971:2012, MDSAP.
  • Establishing business-friendly product development and risk management systems.

Medical Device Consulting Projects:

  • Medical Device Consultant, Consultant team member reporting to a Washington, DC Medical Device legal firm representing a multi-billion-dollar health care supplier. Review organization’s supplier management processes providing improvement recommendations.
  • Management Consultant, Oriel Stat-A-Matrix (orielstat.com) 2021, 2022. Led training classes of ISO 13485:2016 and FDA U.S. 21 CFR Part 820 regulations.
  • Consultant Guide, for the application of U.S. Title 21 CFR Part 820 (Quality Systems Regulations) and U.S. Title 21 CFR Part 4 (Combination Products) to a pharmaceutical company ensuring products’ compliance.
  • Quality Management Consultant, to two start-up medical device companies, and Lead Role for identifying, selecting, and implementing two eQMS systems: Qualio (qualio.com) and Greenlight Guru (www.greenlightguru.com).
  • Medical Device Quality Management Systems Auditor, Quality Auditing, LLC (qualityauditing.com) performing 3rd party internal audits and supplier audits for medical device manufacturers.
  • Manager, Quality Assurance, Helius Medical, Inc.
  • Developed product launch process, led post-market QA activities and product complaint management.
  • Key Quality Management interface for contract design development and manufacturing organizations.
  • Launched effective application of eQMS, Grand Avenue Software (grandavenue.com).
  • Conducted Organizational Capability Assessment, for a pharmaceutical / medical device combination product.
  • Quality Management System Guide, for process improvement, and Training Lead for U.S. Title 21 CFR Part 820 and FDA QSIT audit technique.
  • Lead Auditor and Reviewer, for product, process, system, and software validation activity for 3rd party FDA 21 CFR Part 820, ISO 13485, ISO 14971 and FDA QSIT audit.
  • Consultant Team Leader, for world-wide medical device product development and design control process spanning thirteen (13) global product design centers.
  • FDA Quality Systems Regulation (QSR) Remediation, member of a 16-person team. Led corrective action effort bringing the Japan-Headquartered supplier and purchasing controls into QSR compliance.

ACTAMAX SURGICAL MATERIALS, LLC | Wilmington, DE   2012–2015

Director, Quality Management

50/50 joint venture between DuPont and DSM Biomedical.

  • Managed the Quality Management System creation, establishment, and certification successfully developing an adhesion barrier medical device. Facilitated product development initiatives. Managed one clinical trial site.
  • Achieved quality management systems 3rd party certification and registration to ISO 13485:2012, Medical Device Quality System Requirements, and ISO 14971:2012 Application of Risk Management to Medical Device.
  • Led quality management integration efforts into the business QMS for the Medical Device Directive (MDD) requirements (Annex II, Annex III and Annex V of the EC-Directive 93/42/EEC of 14 June 1993).

E.I. DUPONT DE NEMOURS & CO., INC. | Wilmington, DE   2007–2015

Global Quality Manager – Industrial Biosciences Business Unit

Led product quality and quality management systems in the New Product Development arena. Simultaneously supported Actamax Surgical Materials, LLC joint venture.

  • Established CMO (contract manufacturing organization) critical business processes to facilitate selection, qualification, and support initiatives.
  • Led quality management initiative achieving business launch of an all-natural, all vegetarian Omega-3 dietary supplement.
  • Created/implemented a product development and commercialization system compliant with FDA food (21 CFR Part 110) and dietary supplement (21 CFR Part 111) regulations.
  • Championed EtQ (enterprise quality management) system implementation (etq.com) that managed global manufacturing groups’ customer complaints as well as corrective and preventive actions.

HOLOGIC, INC. | Wilmington, DE   2002–2007

Plant Quality Assurance Manager

Guided/supported manufacturing organization’s FDA regulatory and ISO quality management systems for successful digital mammography detector assemblies production and release.

  • Managed/revised the operations quality and business management systems to ISO 13485:2003 and ISO 14971:2000 standards.
  • Led the organization through a successful FDA site inspection.

Additional Relevant Experience

W.L. GORE & ASSOCIATES, INC. | Elkton, MD  2000–2002
Quality Assurance Associate

  • Managed quality assurance activities for interventional devices under development.

DADE BEHRING, INC.  | Wilmington, DE   1980-2000

(formerly DuPont Medical Products, Diagnostics Division)
Quality Assurance Manager

  • Managed multidisciplinary team for pilot phase implementation of Product Data Management system. Demonstrated product development and manufacturing cycle time reduction feasibility.
  • Delivered annual manufacturing cost reductions of $100K+.
  • Previous roles included:

QA & Compliance Manager

Product Quality Management Engineer

Production Supervisor

QA Supervisor

Process Engineer

Systems Support Engineer

Development Engineer

Education

  • Master of Engineering (ME), Biomedical Engineering, UNIVERSITY OF VIRGINIA, Charlottesville, VA
  • Bachelor of Science (BS), Medical Technology, UNIVERSITY OF BRIDGEPORT, Bridgeport, CT
  • Associate in Science (AS), Electrical Engineering Tech. NORWALK STATE TECHNICAL COLLEGE, Norwalk, CT