Remote Global PMS & QARA Audit Manager (Medical Devices)

Owens & Minor; Richmond (VA); Vor Ort; USD 100.000 - 118.000; Vollzeit

Zusammenfassung

Owens & Minor is seeking a Post Market Surveillance Manager to lead global PMS and QARAC audit programs, ensuring compliance with FDA medical device requirements. This remote role supports teams across the United States and partners with global QA teams to standardize processes.

You will manage a team, drive continuous improvement, maintain audit logs, and deliver monthly metric dashboards while sharing best practices on quality and compliance across Owens & Minor.

Qualifikationen

• Must have experience with FDA reporting and compliance specifically with medical devices.
• Manages and maintains an Owens & Minor Global QARAC Audit program; harmonizes internal audit processes across the organization.
• Experience managing a team; minimum 4–5 years.
• Medical devices experience required.

Aufgaben

• Maintain a centralized log of all internal and third party audits, findings and status of responses.
• Ensure the QARAC audit program and PMS program are compliant and continuously improved.
• Facilitate sharing of best practices/lessons learned across the quality system audit program.
• Generate monthly reports on key process metrics and update the global dashboard.
• Identify and develop qualified internal QARAC auditors and support team leadership.

Kenntnisse

FDA reporting

Leadership

Audit management

Regulatory compliance

Ausbildung

Bachelor's Degree

Jobbeschreibung

Owens & Minor is seeking a Post Market Surveillance Manager to lead global PMS and QARAC audit programs, ensuring compliance with FDA medical device requirements. This remote role supports teams across the United States and partners with global QA teams to standardize processes.

You will manage a team, drive continuous improvement, maintain audit logs, and deliver monthly metric dashboards while sharing best practices on quality and compliance across Owens & Minor.