Quality. Compliance. Success

Professional Certifications

American Society For Quality (ASQ)

• Certified Biomedical Auditor (CBA), Cert. No. 772
• Certified Hazard Analysis And Critical Control Point (HAACP) Auditor (CHA), Cert. No. 787
• Certified Manager Of Quality & Organizational Excellence (CMQ/OE), Cert. No. 3187
• Certified Supplier Quality Professional (CSQP), Cert. No. 574
• Certified Quality Auditor (CQA), Cert. No. 10,459
• Certified Quality Engineer (CQE), Cert. No. 35,016

Villanova University

• Certified Lean Sensei, Villanova University – Lean Six Sigma (Cert. No. Vu2019216)

Exemplar Global

• Qualification Based Medical Device Lead Auditor: Medical Device (Iso 13485:2016) Auditor (Cert. No. 207821)
• Qualification Based Lead Internal Auditor: Medical Device Single Audit Program Internal Auditor (Cert. No. 207821)

Relevant Training

• EU MDR Audit Training (EU MDR 2017/745) (Quality Auditing, January 2023)
• EU MDR Auditor Training (EU MDR 2017/745) (Oriel Stat-A-Matrix, August 2020)
• Conducting A Remote Medical Device QMS Audit (Oriel Stat-A-Matrix, July 2020)
• ISO 14971:2019 Risk Management Training For Medical Devices (Oriel Stat-A-Matrix, July 2020)
• QMS Lead Assessor Course (ISO 9001:2015) Inclusive Of ISO 13485:2016 (Oriel Stat-A-Matrix, June 2020)
• Medical Device Single Audit Program (MDSAP) Criteria From ISO 13485:2016 and Device Regulations For MDSAP  Jurisdictions (Oriel Stat-A-Matrix, June 2020)
• EU MDR Regulation 2017/745 Medical Device Regulation (Axeon, Feb. 28, 2020)

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 3^rd 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