Develops and manages quality systems, including but not limited to CAPA, internal and external audits, validation, and risk management. As an integral member of the RA/QA team, this position ensures all quality system elements are implemented, compliant, effective, and efficient to meet the current and future needs of our sites and facilities worldwide.
- implementation, and effectiveness) are adequately documented and addressed while ensuring timely completion of all CAPA activities.
- Prepare and maintain an annual Internal Audit Schedule and corresponding Internal Audit reports.
- Partner with auditees to ensure the timely completion of actions related to audit findings (including any CAPAs resulting from an Internal Audit).
- Measure, monitor, and report metrics to ensure system effectiveness and efficiency and implement updates/changes as necessary to meet changing business needs.
- Interact and interface with various government agencies, private companies, and consultants (such as US FDA, ANVISA, BSI, etc.) related to Quality System audits/inspections and assist with the timely response to any findings.
- Oversee the Validation Program and collaborate with other departments to ensure software and equipment are appropriately assessed and qualified before use.
- Provide quality guidance and participation in conducting risk management activities, including hazard identification, hazard analysis, failure mode effects and analysis, and risk mitigation.
- Reports to VP of Quality/Regulatory
Typical Education and Experience
- BS Degree in Engineering or Regulatory and 12 years of quality experience in medical device or similar industry.
- 5 years management experience required.