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