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Sr Quality Systems Spec

Fridley, MN 55432

Posted: 10/04/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614020 Is job remote?: No Country: United States

Job Description


The company will be moving records from one electronic system to another, which will result in multiple Quality Management System procedural updates.  This role’s primary responsibility will be to work with document owners on redlines of changes and to create change orders in Agile MAP.  The role will also work with document owners in individual or group meetings to ensure that required changes are made in time to meet the scheduled timeline.

 

Responsibilities may include the following and other duties may be assigned.
  • Supports Quality System/Document Control activities including process and procedure changes and ensures 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 Subject Matter Experts, including Document Owners to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

HM's Top Needs:

1. (STRONG PREFERENCE) Candidate has experience working in MAP Agile or Windchill

2. Candidate has excellent communication and interpersonal skills, working with Document Owners to execute change orders on revised documents

3. Excellent time management skills
 

Education Required: Bachelor’s degree, preferably in science, engineering or related fields

Years’ Experience Required: 4 years of Quality Management Systems and/or medical device experience

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.