Global PMS & QARA Audit Lead (Hybrid—Alpharetta)

Owens & Minor; Alpharetta (GA); Hybrid; USD 100.000 - 118.000; Vollzeit

Benefits dieser Stelle

Health Insurance

Educational Assistance

Employer-Paid Life Insurance

Voluntary Supplemental Programs

Adoption assistance

Fertility benefits

HSA and 401(k)

Paid Leave

Well-Being programs

Zusammenfassung

Owens & Minor is seeking a Post Market Surveillance Manager to lead the global QARAC Audit and PMS programs. The role ensures compliant, efficient processes across regions, coordinating auditors and maintaining documentation logs for findings and responses.

The position requires expertise in FDA medical device reporting, team leadership, and continuous improvement of quality systems. It is a hybrid role based in Alpharetta, GA, with full-time employment and a comprehensive benefits package.

Qualifikationen

• Must have experience with FDA reporting and compliance specifically with medical devices.
• Experience managing a team.
• Maintains centralized log of internal and third party audits, findings and status of responses.

Aufgaben

• Manage and maintain Owens & Minor Global QARAC Audit program with harmonized processes.
• Manage Global PMS program to meet customer and regulatory requirements; ensure eMDR and Vigilance reporting.
• Identify and facilitate a team of qualified internal QARAC auditors.

Kenntnisse

Team leadership

FDA compliance

Audit program management

Data analysis

Process improvement

Jobbeschreibung

Owens & Minor is seeking a Post Market Surveillance Manager to lead the global QARAC Audit and PMS programs. The role ensures compliant, efficient processes across regions, coordinating auditors and maintaining documentation logs for findings and responses.

The position requires expertise in FDA medical device reporting, team leadership, and continuous improvement of quality systems. It is a hybrid role based in Alpharetta, GA, with full-time employment and a comprehensive benefits package.