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Sr Supplier Quality Engineer

IntePros
15 hours ago
Full-time
On-site
Billerica, MA, United States
LinkedIn

We’re seeking a Sr. Supplier Quality Engineer to support supplier quality, product qualification, and continuous improvement activities within a medical device manufacturing environment. Responsibilities Lead Supplier Quality activities and supplier qualification. Support product/component qualification, including test method, equipment, and process validations. Develop product acceptance strategies, receiving inspection requirements, and test methods. Lead Supplier Change Requests and supplier-related NCMRs/CAPA. Monitor supplier performance and resolve quality issues throughout the product lifecycle. Support Approved Supplier List (ASL) activities and supplier audits. Partner with Engineering, Quality, Operations, and suppliers to drive product quality and continuous improvement. Provide technical guidance related to GMP, regulatory, and quality requirements. Communicate supplier quality status, risks, and performance to leadership. Required Experience 3–6 years of relevant experience Medical device industry experience required Bachelor’s degree in Engineering Electrical or Mechanical Engineering background preferred Experience with component/product qualification Strong knowledge of test method validation, equipment/process validation, and process capability Experience with supplier quality, NCMRs, CAPA, audits, and quality systems Ability to work independently and lead cross-functional projects

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