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PECULIAR — Thu, 30 Oct 2008 17:04:57 +0000

CQE with twenty seven years of experience in the Medical Device and Biomedical industries. In- depth knowledge of Regulations and Standards: QSR, ISO 13485, Canadian Medial Devices Conformity Assessment System (CMDCAS), ISO 14971, 21 CFR 1270 & 1271 (Human Tissue).

Titles Held: Vice-President, Quality Assurance; Director of Quality Assurance; Divisional Quality Assurance Engineering Manager; Quality Assurance Supervisor; Production Supervisor

Substantive experience in Design Controls, Product Development, developing Quality System documentation such as Quality Manuals, Policies, SOP’s, Risk Management, CAPA, Supplier Audits
Exceptional understanding of failure investigations, gap analysis, auditing, FDA & ISO inspections, remediation, company acquisitions, and Due Diligence experience
Experience in responding to the FDA on 483’s and Warning Letters
Successfully developed several quality systems for QSR and ISO 13485 compliance
Extensive International QA and auditing experience in Mexico, France, England, Sweden and Japan

H.E.W.

PECULIAR — Thu, 30 Oct 2008 16:51:55 +0000

Biomedical/Manufacturing Quality Engineer with nine years experience in Biomedical Research and Medical Devices. Primary focus is in the area of Quality Assurance, Process Improvement and Design Control.

Titles Held: Quality Engineer; Quality Control Scientist; Biological Chemist

Skilled at performing Design Failure Modes & Effect Analysis (FMEAs), Process Control, Internal
Corporate Audits and Risk Assessments
Test Method Validation, Equipment Validation, DQ, IQ, OQ for New Product Development
Exposure in launching products in Europe, Japan, Germany, Mexico and Puerto Rico
Experience with Class III Implant Devices; Class I and II stints, surgical instruments, ENT and Cardio devices
Working knowledge of governed audits within the FDA, CDC and EPA; strong Biochemist skill set

Medpoint » Biomedical Research

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