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
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