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Quality Systems Program Mgr

Fridley, MN 55432

Posted: 10/10/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614021 Is job remote?: No Country: United States

Job Description


This role’s primary responsibility will be to lead a program that involves transferring medical devices from one internal business to another.  It will include gap assessments for products and the quality management system to determine if any remediation of records will be required.  It involves creating a Quality Plan to document project activities and to identify resources to perform those activities.  The ideal candidate should have the following:
  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
  • Prepares reports and/or necessary documentation (example, Quality Plans) and provides to applicable stakeholders, both internal and external
  • Ensures the quality assurance programs and policies are maintained and modified regularly

HM's Top Needs:

1.  Experience with Program Management for Design Controls, Risk Management and Quality Systems for FDA PMA approved or 510(k)-cleared products.

2.  Developing budget / resource planning for deliverables

3.  Excellent team management skills, leading a team as an individual contributor

Education Required:  Bachelor Degree in Engineering, science

Years’ Experience Required:  8+ years

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Fridley, MN

Unlock your potential in the vibrant community surrounding Fridley, Minnesota! Nestled in the Land of 10,000 Lakes, this region offers a perfect blend of urban amenities and natural beauty. With a plethora of job opportunities in fields like healthcare, manufacturing, and technology, Fridley is a hub for career growth. Imagine evenings spent at the beautiful Springbrook Nature Center, or catching a show at the historic Banfill-Locke Center for the Arts. Don't miss out on the chance to explore the Mississippi River by taking a stroll along the Riverfront Regional Park. Join our team and discover why Fridley is the ideal place to take your career to new heights!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.