Supplier Quality Assurance Specialist

3 weeks ago


Plymouth, Minnesota, United States Abbott Full time

About the Role

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

We are seeking a Supplier Quality Engineer I to support the selection, approval and maintenance of our Electrophysiology division's approved suppliers. As a key member of our team, you will perform supplier quality system assessments, monitor supplier performance, and drive supplier corrective action and/or improvement activities.

Key Responsibilities

  • Ensure the Division Approved Supplier List is maintained and accurate.
  • Assess potential new suppliers and service providers for quality and quality system capabilities through on-site or desk top audits, and review of other objective evidence.
  • Communicate Division approval requirements to suppliers and monitor feedback per project timelines.
  • Support on-site quality assessments of new suppliers, as required, and ensure appropriate corrective action response to findings.
  • Evaluate Exception Reports (NCMRs) issued for nonconforming supplied material and work with the supplier on the investigation and resolution of root cause issues.
  • Notify suppliers of customer complaints related to failures resulting from supplied material and require investigation and corrective action.
  • Monitor supplier performance and report supplier quality trend data.
  • Participate with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program.
  • Responsible for approving First Article Inspections, as initiated by suppliers.
  • Assist with the evaluation and approval of supplier requested changes or improvements.

Requirements

  • Bachelor's degree in Engineering or Science discipline.
  • 3 years related Quality Assurance experience in the medical device or pharmaceutical, or other quality managed industries.
  • Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD.

About Abbott

Abbott is an Equal Opportunity Employer, committed to employee diversity. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please contact us.



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