Expert Details

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

Expert ID: 723723 North Carolina, USA

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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.

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.

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 - Greenville, South Carolina

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 1991 to Present Employer: Undisclosed Title: owner/principal Department: Responsibilities: He is a QA/RA professional, owner and principal consultant to medical devices industry and manufacturing QC, serving clients nationwide since 1991.
Years: 1978 to 1988 Employer: GTE Products Title: Quality Engr. Manager Department: Sylvania/Electronic Components Div. Responsibilities: Quality engineering and systems management, for commercial and industrial plastic components used principally in electronics, lighting and medical device applications.
Years: 1988 to 1990 Employer: Eaton Corp Title: Quality Engineer & Instructor Department: Research & Development Center Responsibilities: Developed and delivered training & consulting in quality engineering, process optimization, tool and GR&R studies

Government Experience

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

International Experience

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

Career Accomplishments

Associations / Societies
Senior Member American Society for Quality;
KofC 4th degree;
SPI/SPE;
Professional Photographers of NC
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
Publications and Patents Summary
He has several publications in quality and industrial journals, a published book, and published/presented paper at World Quality Congress.

Additional Experience

Expert Witness Experience
Paralegal experience
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
Vendor Selection
He has designed and implemented criteria based supplier quality evaluation programs for automotive base.
Marketing Experience
As principal owner, responsible for company mission, marketing and sales.
Other Relevant Experience
Certified and Registered QMS Lead Assessor;
Lead Technical Assessor for Laboratory Accreditation

Language Skills

Language Proficiency
French Fluent reading/writing. Intermediate speaking

Fields of Expertise

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, photography, 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, American National Standards Institute, first article inspection, supplier quality engineering, acceptable quality level, printing quality control, 510(k) document, design-for-quality, textile quality control, photographic materials processing, printing plate, photographic material, acceptance sampling, statistical computer software, electronics manufacturing quality control, standard quality program development, coordinate measuring machine, graphics primitive, continuous quality improvement, American National Standards Institute material standard, graphic arts, biomedical device, Taguchi method, industrial engineering, statistics, offset printing, color quality control

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