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Expert in Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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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.
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Show Secondary and Basic Areas of Expertise | Localities:
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.
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Degree |
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Subject |
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Institution |
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Honors |
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1988
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Master of Science
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Industrial Mfg. Technology
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Western Carolina University
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cum laude
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1976
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Bachelor of Science
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Broadcast Communications
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Temple University
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cum laude
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Employer |
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Department |
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Title |
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Responsibilities |
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1991 to
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(Undisclosed)
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owner/principal
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He is a QA/RA professional, owner and principal consultant to medical devices industry and manufacturing QC, serving clients nationwide since 1991.
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1978 to 1988
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GTE Products
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Sylvania/Electronic Components Div.
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Quality Engr. Manager
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Quality engineering and systems management, for commercial and industrial plastic components used principally in electronics, lighting and medical device applications.
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1988 to 1990
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Eaton Corp
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Research & Development Center
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Quality Engineer & Instructor
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Developed and delivered training & consulting in quality engineering, process optimization, tool and GR&R studies
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Associations/Societies
Senior Member American Society for Quality;
KofC 4th degree;
SPI/SPE;
Professional Photographers of NC
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Licenses/Certifications
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
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| Publications: |
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Publications and Patents Summary
He has several publications in quality and industrial journals, a published book, and published/presented paper at World Quality Congress.
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| Government Experience: |
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Agency |
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Role |
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Description |
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1989 to 1991
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DSCI
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Inspector Supv
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Inspection supervision for MIL-I qualified components into Defense program
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| Selected Consulting Examples: |
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Medical Devices, conformance requirements to international quality system standards; compliance to applicable device regulations in U.S., E.U. and Canada.
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Plastics molding, specialty injection molding of precision components used prinicipally in automotive, aerospace, electronics and medical device industries.
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Printing and publishing, including pre-press, graphic arts and offset printing.
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Automotive, specialty in engine components and transmissions, quality systems and associated AIAG core tools requirements for production part approvals.
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Recent Client Requests:
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APQP expert for consulting on APQP training and documentation.
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Expert for consulting on Quality Assurance Assessment.
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Fda medical device mock audit for consulting on Mock audit to 21CFR820.
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Expert for consulting on Need - ISO 17025 Internal Auditor.
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EU cosmetic expert for consulting on advising CTO to meet 76/768/EEC requirements.
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Expert in Capability Study for Product Dimension Control - Food Manufacturing.
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Automotive expert in passive safety systems and engineering plastics.
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ELAP laboratory accreditation expert for consulting on lab accreditation in CA for 8260B.
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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.
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Expert Witness Experience Summary:
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Paralegal experience
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Recent Litigation Client Requests:
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FDA expert witnesses for consulting on FDA medical device and supply chain/distribution.
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Cardiac electrophysiology expert witness for consulting on proper defibrillator (AED) maintenance.
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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.
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| International Experience: |
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Country / Region |
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Summary |
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2005 to 2006
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Ireland
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Consulting and training in medical devices operations, Westport Ireland, based in CAL.
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2004 to 2005
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Belgium and Wales
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Principal consultant on automotive TS16949 QMS implementation in polymers industry, four sites, two in U.S. for company wide registration, achieved 2005.
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2002 to 2007
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Mexico
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On-site laboratory assessments for lab accreditation, principally at MX satellite operations of U.S. automotive suppliers and testing labs
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| Language Skills: |
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| Foreign Language |
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Description |
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French
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Fluent reading/writing.
Intermediate speaking
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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.
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| Additional Skills and Services: |
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Training/Seminars
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
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Supplier and Vendor Location and Selection He has designed and implemented criteria based supplier quality evaluation programs for automotive base.
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Other Skills and Services
Certified and Registered QMS Lead Assessor;
Lead Technical Assessor for Laboratory Accreditation
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Education
