PROFESSIONAL EXPERIENCE
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
Education
St. Edwards University, Austin Texas - MBA Candidate – Incomplete
California Polytechnic State University - BS Mechanical Engineering
Waterbury State Technical College - AS Mechanical Engineering Technology
Programs
Management Development Program – Rensselaer Polytechnic Institute
Quality Engineering School – ETI/ASQC
Quality Education Management – Philip Crosby and Associates
Quality Management Seminar - Dr. Deming
Certification
ASQ Certified Quality Engineer
ASQ Certified Quality Manager
RAPS Regulatory Affairs Certified