Senior QA/RA Consultant


Strategic, technical and managerial leader who is mission-focused, good in a crisis, and has extensive skills and experience in internal and supplier-based product development and manufacturing; extensive knowledge of design, operations and quality systems for CT/MRI, Electrophysiology, Endoscopy, Cardiology, Orthopedics, Pharmacologic and Biologic Wound Care and Device/Pharma combo products, as well as aerospace and oil field technology.

  • Executive Management – Led global QA and RA functions, re-aligning company strategies with broad QA and RA initiatives, integrating company-wide Quality Systems and enterprise platforms.
  • Product Development – Provided technical expertise to the Development and Design Review process; configured and led many Design Review Boards and Design Transfer, validation and verification initiatives.
  • Manufacturing – Provided Quality and Process Engineering support; led Engineering and Production functions; supervised and participated in process validation, process control, supplier quality and product verification initiatives.
  • Product Management – Delivered multiple in-house and OEM developed products to market; led many of these projects.
  • International Business Management – Identified and qualified many foreign companies in Europe, Canada, Mexico, Australia and China.
  • Global Service and Repair – Led initiatives to globalize a worldwide service network for electronic equipment maintenance, service and repair.
  • Regulatory Compliance – Led and executed numerous GXP initiatives for assuring compliance to 21 CFR 210, 211, 610, 801, 802 & 820, ISO 9001, ISO 13485, UL 60601 & ANSI/AAMI ES60601-1, ISO 14971, ISO 14001 and other standards; led and participated in many QS remediation activities
  • Regulatory Affairs – Oversaw the writing and revision of product 510(k)’s, PMA Supplements and annual PMA reports



Johnson & Johnson, Inc. 2017 - Present

Quality System Consultant

  • Revising the J&J device Quality System to comply with ISO13485:2016 and newly issued EU Medical Device Regulation; harmonizing the medical device Quality System where practical.

Philips Medical 2016 - 2017

Design QA SME (consultant)

  • Serving as DQA authority overseeing the resolution of product defects and changes in response to FDA Form 483 commitments and mainstream product development.

Smith & Nephew, Inc. 2012 - 2015

Senior Director, Corporate Quality System

  • Developed and implemented a single, global Quality System for all S&N operations worldwide, streamlining and standardizing key business processes.
  • Was key architect of Smith &Nephew’s QARA reorganization’ from a decentralized amalgam of separate QA and RA functions into a single global function.
  • Developed the algorithm that mapped the savings potential resulting from reorganizing and standardizing the Quality System, confirming potential saving and cost avoidance exceeding $500M over 5 years.
  • Introduced a new Regulatory Compliance function that drove global CAPA and Corporate Audit action completion and effectiveness.
  • Introduced a new global Training function to promulgate the new Quality System and implement standardized GxP training globally.
  • Developed global QARA Metrics reporting system; analyzed monthly performance for trends and put forward recommendations for improvements.
  • Led new Global Complaint Program that installed and standardized a single software system (Pilgrim) and complaint handling process across all multinational sites
  • Participated in the revalidation of our biologics production facility and clean rooms for Santyl Collagenase biologic ointment

C.R. Bard, Inc. 1992 - 2011

Vice President – QA/RA

  • Multi-site responsibility, including factories in US, Puerto Rico, EU and China.
  • Served as interim head of QA for Bard Cardiology Group, which included USCI, Electrophysiology, Cardiopulmonary, and Cardiac Assist Divisions, oversaw their divestiture.
  • Established Shared Services group that centralized Document Control, Field Assurance, Sterility Testing and Biological Assurance, Material Characterization, Blood Lab, Design Verification Testing, and Internal Auditing.
  • Negotiated and led a $2.1M QA expansion program with Bard Corporate to develop and expand the QE and Quality Systems function for the fledgling Electrophysiology Division.
  • Led all QA functions including Design Assurance, Inspection and Test, Supplier QA, Document Control, Field Assurance, Regulatory Affairs, and Quality Systems.
  • Conducted design verification and validation testing, process validation, technology transfer, ranging studies, designed experiments; installed SPC.
  • Efforts resulted in a ramp up of the product development portfolio from 3 to 12 active projects, and a new product launch every 9 months.
  • Hosted all 3rd party audits, and served as Management Representative.
  • Achieved and maintained the Endoscopic Technologies division’s first ISO 9001 and 13485:2003 certifications.
  • At the Bard Endoscopic Technologies Division, achieved 5 consecutive years of reduced customer complaints and lot rejections at all manufacturing locations.
  • Improved supplier performance, and reduced quality cost as a percent of COGS.


Staff QA Director

  • Reduced product rejection rates from 18.4% to 2.5% through the design, development and implementation of new supplier qualification requirements; streamlined the NCM/MRB process, eliminating backlog of nonconforming material and getting average disposition times to less than 15 days.
  • Improved equipment service in all markets including the EU by renegotiation of OEM supply quality agreements with device manufacturers. 
  • Received no related non-conformances from FDA/ISO audits after implementing supplier management system in accordance with recent FDA and EU regulatory changes.
  • Introduced 8 new products via OEM new product development and distribution programs; streamlined the supplier qualification process to improve the time-to-market of OEM products by 50%.
  • Reduced Inspection and Test time by 62% while reducing turn-time from 15.2 to 2.6 days by eliminating unnecessary inspections and tests, improving methods and Technician skills.


Previous Employment


JOHNSON & JOHNSON, INC. - Ethicon Endo-Surgical

Quality Engineering Manager


INTERMEDICS, INC. - Orthopedic Division

Quality Assurance Manager


TRACOR, INC. - Aerospace Division

Procurement QA Manager, QC Supervisor, Sr. Quality Engineer


HUGHES TOOL COMPANY - BJ Hughes Oilfield Tooling and Service Division

Senior Design Engineer




St. Edwards University, Austin Texas - MBA Candidate – Incomplete

California Polytechnic State University - BS Mechanical Engineering 

Waterbury State Technical College - AS Mechanical Engineering Technology



Management Development Program – Rensselaer Polytechnic Institute

Quality Engineering School – ETI/ASQC

Quality Education Management – Philip Crosby and Associates

Quality Management Seminar - Dr. Deming



ASQ Certified Quality Engineer

ASQ Certified Quality Manager

RAPS Regulatory Affairs Certified

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