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
#LI-KS1
