Director of Quality/Regulatory- Medical

 

 

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.

 

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