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Sr. Quality Systems Specialist

2 months ago

Minneapolis, United States Planet Pharma Full time

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