Responsible for ensuring the delivery of high-quality, life-saving products by managing supplier quality throughout the product lifecycle—from development through production.
Collaborates cross-functionally with R&D, Supply Chain, and external suppliers to assess and monitor supplier quality systems, drive process improvements, and ensure compliance with regulatory and internal standards.
Key responsibilities include supplier approval coordination, developing and maintaining weekly and monthly quality metrics—including Supplier Approvals, Scorecards, SCARs, and Process Quality—to support data-driven decision-making and continuous improvement.
Supports supplier audits and corrective action initiatives across the supply base.
Requirements
Bachelor's degree in engineering or technical science, or equivalent combination of education and directly relevant experience.
3+ years’ directly relevant experience, with prior experience in an FDA/cGMP or regulated environment.
Working knowledge of PPAP and IQ/OQ/PQ validation techniques.
Strong written and verbal communication skills.
Direct experience as a Manufacturing Engineer, Test Engineer, Quality Engineer, or Supplier Quality Engineer.
Certified quality auditor.
Experienced with six-sigma and lean manufacturing techniques.
Direct experience working with class 3 medical devices.
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