Post Market Surveillance Manager (Medical Devices)

Post Market Surveillance Manager (Medical Devices)

The Post Market Surveillance Manager is a key contributor to the success of the Owens & Minor QARA organization. The Manager is responsible for establishing an efficient and effective global program to audit quality systems and compliance areas such as FCPA and an effective and compliant Post Market Surveillance (PMS) program. This is a global role that supports all Owens & Minor and ensures the Global QARAC Audit and PMS Program is compliant with applicable standards and regulations and is devoid of complexity that reduces effectiveness and/or efficiency whilst empowering teammates to improve outcomes. This role hybrid located in Alpharetta, Georgia.

Specific Functional Areas and Experience:

• Must have experience with FDA reporting and compliance specifically with medical devices.
• Manages and maintains an Owens & Minor Global QARAC Audit program that:
• Harmonizes QARA and Compliance internal audit processes across Owens & Minor to meet customer and regulatory requirements; continuously monitored and improved; execute proficient auditors using appropriate audit protocols.
• devoid of complexity that reduces effectiveness and/or efficiency and empowers teammates to improve outcomes.
• Manages and maintains an Owens & Minor Global PMS program that: Harmonizes PMS processes across Owens & Minor to meet customer and regulatory requirements;
• Meets all requirements in terms of eMDR and Vigilance reporting; Is continuously monitored and improved.
• supports the effective execution of the QARAC audit program:
• Responsible for identifying and facilitating a team of qualified, independent internal QARAC auditors.
• Maintains a centralized log of all internal and third party audits, findings and status of responses.
• Accountable for the centralized maintenance of all documentation including subsequent follow up, tracking and closure of any findings that result from such audits.
• Facilitates the sharing of best practices / learnings and initiatives from the quality system audit program throughout Owens & Minor.
• identifies and shares industry best practices.
• Conducts proactive data analysis and promotes a culture of continuous improvement to identify opportunities and improve the Owens & Minor global quality and compliance systems.
• Ensures monthly reports are available on key process metrics and are represented on the global dashboard.
• experience managing a team
• minimum 4-5 yrs experience
• Bachelors Degree
• Medical devices experience (required)

If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

You Belong at Owens & Minor

At Owens & Minor, our greatest strength is the unrivaled dedication of our teammates. Powered by more than 14,000 teammates worldwide, Owens & Minor delivers comfort and confidence behind the scenes so healthcare stays at the forefront. The contributions, experiences, and perspectives of all our teammates helps strengthen our company as we innovate and grow to serve our healthcare customers. We appreciate your interest in joining Team O&M!

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