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Quality Assurance Specialist 3

United States of America, Irvine · Job Posted May 14, 2026
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Job Description

Quality Assurance Specialist 3 responsible for managing supplier quality activities, ensuring compliance with regulatory standards, monitoring supplier performance, and supporting quality systems within a regulated medical device environment.

Job Responsibility

  • Manage supplier qualification, monitoring, and re-evaluation activities
  • Ensure compliance with purchasing controls and quality regulations
  • Monitor supplier performance using KPIs, defect trends, and risk analysis
  • Maintain Approved Supplier Lists (ASL) and supplier quality records
  • Issue, track, and evaluate supplier change requests
  • Escalate supplier quality risks and support remediation plans
  • Review supplier or internal changes impacting product quality or compliance
  • Collaborate with Engineering and Regulatory teams on validation and impact assessments
  • Provide supplier quality inputs for management reviews and quality metrics
  • Maintain accurate documentation within the electronic Quality Management System (eQMS)
  • Ensure supplier activities align with internal procedures and regulatory expectations

Requirements

  • 2–5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing
  • Experience in medical device or regulated environments preferred
  • Bachelor’s degree in Engineering, Quality, or related field
  • Equivalent experience may also be considered

Nice to have

Experience in medical device or regulated environments preferred

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