Post Market Surveillance Manager (Medical Devices)

United States·Alpharettamid

Other

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Quick Summary

Requirements Summary

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.

Technical Tools

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Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.

140+ years serving healthcare
Over 14,000 teammates worldwide
Serving healthcare partners in 80 countries
Manufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland
40+ distribution centers
Portfolio of 300 propriety and branded product offerings
1,000 branded medical product suppliers
4,000 healthcare partners served

What We Offer

~2 min read

✓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)

Location & Eligibility

Where is the job

Alpharetta, United States

On-site at the office

Who can apply

About this job

Pay per year: $100,000–$118,000 a year; 61% above the $67,500 median for Other jobs on Jobera (119,193 salaries).
Who can apply: United States
Posted: 25 days ago
Employer: has 80 open jobs on Jobera.