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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