Demonstrate dedication and commitmnet to patient safety or product performance. Ensure quality system meets or exceeds requirements for FDA and/or ISO. Ensure quality elements are met and documented.

COMPANY	POSITION HELD	DATES WORKED
LifeCell	Sr. Quality Compliance Auditor	6/2008 - 11/2009
Advanced Biomaterial Systems	VP Quality Assurance - Management Representative for Quality Systems	4/2003 - 6/2008
(Confidential)	Secretary General	9/2001 - Present
Met Life	Project Manager	9/2000 - 2/2003
Rheometric Scientific	ISO Quality Officer	6/1989 - 9/2000
Lockheed Electronics Company	Senior Technical Writer	4/1985 - 6/1989

SCHOOL	MAJOR	YEAR	DEGREE
RETS Electronic School	Electronic Circuit Theory and Design	1982	Associate Degree
Mid Valley School of Law	Contracts	1978	Specialist Degree
Franklin Pierce University	English	1977	Bachelor Degree

Highlights:

Developed/implemented and achieved certificationfor ISO 9001 for company in US, UK and Germany Developed supplier qualification program for human implant products Perform internal and external audits to ensure process and supplier compliance Installed and validated clean room in warehouse area Provide training for GMP requirements Perform internal/external audits for compliance and CAPA actions CAPA action for resolution and effectiveness Secured CE marking for medical devices in accordance with MDD 93/42

Companies I like:

Medical Device, Manufacturing with ISO certification

Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts.
Sales Support
Software Implementation
Requirements Analysis & Specification
Leadership

• Quality Auditor
• Compliance
• Biotechnical
• Medical Device Manufacture
• Manufacturing

Certified Quality Auditor through ASQ ISO 9001/13485 Management Representative