P.A.A.

PECULIAR — Thu, 30 Oct 2008 17:10:06 +0000

A driven professional with eleven years experience. Extensive knowledge in Documentation for both the Medical Device industry as well as Engineering firms.

Titles Held: Documentation Coordinator; Documentation Technician; Business Manager

Possesses a great deal of experience in a variety of areas including an in-depth knowledge of computers, peripherals, installing hardware, software and troubleshooting
Experienced with Class II and III medical devices, mostly disposables
Efficient with QMIS database, SAP and CAD
Strong documentation skills, reporting, coordination and follow through
Has worked with start up to large medical device firms

E.C.W.

PECULIAR — Sat, 25 Oct 2008 15:44:14 +0000

Thirty year veteran in the medical device arena, including thirteen years working for the FDA as engineer/field investigator and supervisor specializing in medical devices. Has worked with a wide range of FDA and international requirements while solving regulatory compliance issues and improving quality systems.

Titles Held: Director of Quality Assurance; Manager of Regulatory Compliance; Manager of Quality Assurance Engineering; Associate Manager of QA Engineering

Well experienced in FDA issues including remediation of FDA-483 observations, warning letters, recalls, and consent decrees
Has conducted medical device quality system compliance (QSR and/or ISO 13485) audits in Canada, China, Puerto Rico, Ireland, England, Germany, EU, and Mexico
Resolved large backlog of medical device complaints, risk analysis, and investigations
Managed remediation programs and resolved non-compliance issues leading to ISO certification and PMA & 510k approvals
Experienced with multi-facility corporate quality assurance and regulatory compliance programs

Medpoint » Engineering

P.A.A.

E.C.W.