Supplier Quality Engineer I

3 days ago

Minneapolis, Minnesota, United States Abbott Laboratories Full time
About Abbott

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.

Our Culture

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

Job Summary

As the Supplier Quality Engineer I, you'll support in the selection, approval and maintenance of EP's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.

Key Responsibilities
  • Ensures that the Division Approved Supplier List is maintained and accurate.
  • Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desk top audits, and review of other objective evidence, as required.
  • Communicates Division approval requirements to supplier and monitors feedback per project timelines.
  • Supports on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.
  • Evaluates Exception Reports (NCMRs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.
  • Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.
  • Monitors supplier performance and reports supplier quality trend data.
  • Participates 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.
  • Assists with the evaluation and approval of supplier requested changes or improvements.
Requirements
  • Bachelor's degree in Engineering or Science discipline.
  • 1-3 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.

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