Supplier Quality Assurance Specialist
3 weeks ago
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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