Sr Quality Systems Spec - Exempt

Job Title

Candidate has experience working in MAP Agile or Windchill

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

Excellent time management skills our client 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.

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.

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

Will the contractor be working 40 hours a week? If not, weekly estimate? 20 hours per week is planned

Work Location:

Rice Creek Facility in Fridley, MN

Does this person need to be local to any MDT office and if so where? Yes, Rice Creek facility

Does this person need to be on site? If so, full time or part time? On site (our current requirement at Rice Creek is 3 days/week in office, so I think we'd want them to be on site for all their hours)