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Sr Quality Systems Spec
7000 Central Avenue Northeast Fridley, MN 55432 US
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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