Overview In this role you ensure supplier quality across the product lifecycle, aligning suppliers with company and regulatory standards. You will work with cross-functional teams to prevent defects and support high-quality, reliable products. You will define receiving inspection needs and test validations, driving continuous improvement and compliance. The role focuses on medical device or automotive qualification requirements and supplier development to meet customer expectations. This position offers impact by shaping supplier quality strategies and quality assurance practices.
Responsibilities- Ensure suppliers deliver quality parts, materials, and services
- Qualify suppliers and administer a Certified Supplier Program in receiving inspection
- Monitor parts from acquisition through manufacturing and resolve supplier issues
- Evaluate suppliers' internal capabilities and provide performance feedback
- Collaborate with R&D, sourcing, engineering, operations, and quality to prevent defects
- Provide technical guidance on quality compliance throughout the product lifecycle
- Contribute to Product Acceptance Sampling Strategy, Approved Supplier List, Supplier Owned Quality deployment, and Control Plans for new products
- Define receiving inspection requirements and test method validation for internal methods
Key requirements- Bachelors degree
- Minimum 4 years of relevant experience (or advanced degree with 2 years)
- Experience in Medical Device Industry or Automotive part qualification
- Knowledge of ISO 13485 and FDA QMSR
- Geometric tolerances
- Practical knowledge of project management (desirable)
- Cross-functional collaboration
- Quality-focused mindset
- Problem solving
- TrackWise (experience a plus)
- Geometric tolerances
- ISO 13485
