Owens & Minor

Post Market Surveillance Manager (Medical Devices)

Owens & Minor • $100K — $118K *
US-AnywhereRemote in United States
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 4-5 years of experience in post-market surveillance and quality assurance for medical devices.
  • Experience with FDA reporting and compliance specific to medical devices.
  • Bachelor's degree in a relevant field.
  • Proven ability to manage and maintain quality audit programs.
  • Experience leading teams and facilitating collaboration among auditors.

Responsibilities

  • Establish an efficient global audit program for compliance and quality systems.
  • Harmonize audit processes across the organization to meet regulatory requirements.
  • Manage compliance with eMDR and Vigilance reporting for the PMS program.
  • Facilitate the development of a skilled team of internal auditors.
  • Maintain comprehensive logs of audits, findings, and follow-up actions.
  • Conduct proactive data analysis to identify opportunities for system improvements.
  • Ensure timely reporting of key metrics on a global dashboard.

Benefits

  • Remote work opportunity within the United States.
  • Chance to lead global quality assurance initiatives.
  • Access to industry best practices and continuous improvement initiatives.
  • Opportunity to influence compliance standards and practices across a major medical devices organization.
Full Job Description

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 is remote and accepts applications within the United States.

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.

About Owens & Minor

Owens & Minor, Inc. (NYSE: OMI) is a global healthcare solutions company that incorporates product manufacturing, distribution support and innovative technology services to deliver significant and sustained value across the breadth of the industry – from acute care to patients in their home. Aligned to its Mission of Empowering Our Customers to Advance HealthcareTM, more than 15,000 global teammates serve over 4,000 healthcare industry customers. A vertically-integrated, predominantly Americas-based footprint enables Owens & Minor to reliably supply its self-manufactured surgical and PPE products.

Owens & Minor Careers

Join the dynamic team at Owens & Minor, a leading global healthcare solutions company. With a rich history and a vibrant culture of innovation and leadership, there has never been a better time to explore job opportunities with us. Work You’ll Do At Owens & Minor, we empower our team to drive the healthcare industry forward through cutting-edge solutions and unparalleled client service. Our commitment to diversity and professional growth makes Owens & Minor not just a workplace but a place to build a meaningful career. Transform the Healthcare Industry Join our team to help healthcare organizations operate more efficiently and effectively using our innovative supply chain solutions. At Owens & Minor, you will work alongside industry experts dedicated to improving patient outcomes and reducing healthcare costs. Lead with Us Step into a role that harnesses your skills and passion for leadership. Owens & Minor is uniquely positioned at the intersection of healthcare solutions and technological innovation, providing a platform for professional growth and industry leadership. Collaborate with Experts Become part of a global team that values collaboration and diversity. Our network of professionals spans across continents, all working together to make a significant impact in healthcare. With over 15,000 dedicated team members, your potential for networking and professional development is expansive. Owens & Minor Jobs and Internship Programs We offer a range of career and internship opportunities designed to attract the best and brightest. Whether you're a seasoned professional or a recent graduate, Owens & Minor provides the tools and training to take your career to the next level. Innovate with Us Engage in work that challenges and fulfills you. Owens & Minor is at the forefront of healthcare innovation, constantly seeking better ways to serve our clients through advanced technology and strategic insights. Be Part of Our Culture Experience a culture that promotes career growth and supports your personal and professional development. Owens & Minor is committed to offering benefits that enhance your life and work, including comprehensive health benefits, diversity training, and flexible working arrangements. Future-Proof Your Career With Owens & Minor, the path to success is filled with opportunities to advance. Our supportive environment is designed to cultivate your talents through ongoing training and leadership programs. Explore Discover how Owens & Minor is revolutionizing healthcare: - Implementing advanced distribution strategies to enhance supply chain efficiency. - Leveraging data analytics to predict healthcare trends and improve client service. The Owens & Minor Difference Our combined expertise in healthcare solutions and our commitment to innovation and diversity make Owens & Minor a leader in the industry. Clients and healthcare providers trust Owens & Minor to deliver operational excellence and drive transformative outcomes. Stay Connected Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. SEARCH OWENS & MINOR JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Owens & Minor.
Learn more about Owens & Minor
Size
6,900 employees
Market Cap
$1.4 billion
Industry
Healthcare
Net Income
$29.8 million
Founded
1882
5 Year Trend
+0.1%
Revenue
$8.4 billion
NASDAQ
OMI
* Ladders Estimates

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