Sr Supplier Quality Engineer

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