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 Expert  723723

Expert in Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification

Available for your Consulting and Expert Witness Needs

North Carolina (NC)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. He offers full range of quality system planning, design/development, process optimization, implementation, training and auditing.

He provides expert consulting in ISO-9000, ISO-13485, QS 9000, TS 16949, FDA-QSR, Medical Device Directives, CE Marking, Quality Engineering and process optimization. He offers training in CQE, CMI, APQP, SPC, FMEA, MSA, PPAP, Taguchi Methods, Risk Analysis, Internal Auditing, ISO 17025, ISO 15189, and Problem Solving. He conducts capability studies and QMS assessments with contracts to 3rd party registrars and independent 3rd party. Expert is experienced in new venture start-ups, matured business systems and re-engineering of systems.


acceptance test


American Society for Quality Control


automotive quality


British Standards Institution


capability study


CE Marking


FDA medical device regulation


foreign medical device regulation


ISO 9000 auditing


ISO 9000 series quality system standard


laboratory accreditation


machine capability study


medical device manufacturing quality control


Medical Device Reporting regulation


medical regulation




plastics quality control


probability distribution


process capability study


QS-9000 quality system requirements


quality assurance


quality assurance management system


quality auditing


quality control


quality documentation product


quality engineering


quality evaluation


quality management


quality standard


statistical data analysis


statistical process control


statistical quality control


total quality control


vendor quality auditing

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Charlotte, North Carolina;  Asheville, North Carolina;  Gastonia, North Carolina;  Knoxville, Tennessee;  Johnson City, Tennessee;  and Greenville, South Carolina.

Often requested
with this expert:

Biotechnology Product Reviews, Biologics, Drugs & Medical...
Machinery CE-Marking, Medical Device CE-Marking, CE-Marking...
Supplier Quality Assurance, Cost Improvement Projects, ISO...
ISO 9001-2000/ TS 16949 audits, documentation, training,...

Year   Degree   Subject   Institution   Honors
1988   Master of Science   Industrial Mfg. Technology   Western Carolina University   cum laude
1976   Bachelor of Science   Broadcast Communications   Temple University   cum laude

Work History:
Years   Employer   Department   Title   Responsibilities

1991 to







He is a QA/RA professional, owner and principal consultant to medical devices industry and manufacturing QC, serving clients nationwide since 1991.

1978 to 1988


GTE Products


Sylvania/Electronic Components Div.


Quality Engr. Manager


Quality engineering and systems management, for commercial and industrial plastic components used principally in electronics, lighting and medical device applications.

1988 to 1990


Eaton Corp


Research & Development Center


Quality Engineer & Instructor


Developed and delivered training & consulting in quality engineering, process optimization, tool and GR&R studies

Career Accomplishments:

Senior Member American Society for Quality; KofC 4th degree; SPI/SPE; Professional Photographers of NC


IRCA QMS 2000 Principal Auditor (1995); RAB/QSA QMS Lead Assessor (1996); ASQ Certified Quality Engineer (1982); ASQ Certified Quality Manager (1998); American Society for Quality Senior Member (1981); Listed Certified Medical Devices Consultant, Canon Publications; AIAG Certified QS-9000 Lead Assessor, (expired); BSI/CEEM Certified EMS Lead Auditor, (2000); Certified Professional Photographers of America; Water Safety Instructor WSI and NAUI/PADI Certified Diver

Publications and Patents Summary

He has several publications in quality and industrial journals, a published book, and published/presented paper at World Quality Congress.

Government Experience:
Years   Agency   Role   Description
1989 to 1991   DSCI   Inspector Supv   Inspection supervision for MIL-I qualified components into Defense program

Consulting Services:
Selected Consulting Examples:
  • Medical Devices, conformance requirements to international quality system standards; compliance to applicable device regulations in U.S., E.U. and Canada.
  • Plastics molding, specialty injection molding of precision components used prinicipally in automotive, aerospace, electronics and medical device industries.
  • Printing and publishing, including pre-press, graphic arts and offset printing.
  • Automotive, specialty in engine components and transmissions, quality systems and associated AIAG core tools requirements for production part approvals.
Recent Client Requests:
  • APQP expert for consulting on APQP training and documentation.
  • Expert for consulting on Quality Assurance Assessment.
  • Fda medical device mock audit for consulting on Mock audit to 21CFR820.
  • Expert for consulting on Need - ISO 17025 Internal Auditor.
  • EU cosmetic expert for consulting on advising CTO to meet 76/768/EEC requirements.
  • Expert in Capability Study for Product Dimension Control - Food Manufacturing.
  • Automotive expert in passive safety systems and engineering plastics.
  • ELAP laboratory accreditation expert for consulting on lab accreditation in CA for 8260B.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Paralegal experience
Recent Litigation Client Requests:
  • FDA expert witnesses for consulting on FDA medical device and supply chain/distribution.
  • Cardiac electrophysiology expert witness for consulting on proper defibrillator (AED) maintenance.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2005 to 2006   Ireland   Consulting and training in medical devices operations, Westport Ireland, based in CAL.
2004 to 2005   Belgium and Wales   Principal consultant on automotive TS16949 QMS implementation in polymers industry, four sites, two in U.S. for company wide registration, achieved 2005.
2002 to 2007   Mexico   On-site laboratory assessments for lab accreditation, principally at MX satellite operations of U.S. automotive suppliers and testing labs

Language Skills:
Foreign Language   Description
French   Fluent reading/writing. Intermediate speaking

Market Research:
As principal owner, responsible for company mission, marketing and sales.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

Highly experienced in developing and presenting training courses/seminars in all aspects of the quality sciences, primarily in Quality Systems, Medical Device Regulations, Laboratory Accreditation and Automotive Core Tools Skills

Supplier and Vendor Location and Selection

He has designed and implemented criteria based supplier quality evaluation programs for automotive base.

Other Skills and Services

Certified and Registered QMS Lead Assessor; Lead Technical Assessor for Laboratory Accreditation


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