Sr Supplier Quality Engineer
Katalyst CRO · Louisville, CO · 1 wk ago
HybridQuality AssuranceContract
Roles And Responsibilities
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Maintains an auditing schedule to ensure designated suppliers are audited regularly to meet GMP and quality standards.
- Evaluates suppliers' internal functions to assess their performance and provides feedback.
- Supports New Product Development (NPD) by providing Pre-Market Quality Engineering support, collaborating with Component Engineering and Post-Market Supplier Quality Teams, and ensuring quality parts, materials, and services are delivered.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle, including evaluating newly qualified parts and implementing strategies for driving product quality and continuous improvement.
- Collaborates with Component Engineers to develop and deliver Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Defines Receiving Inspection requirements and associated test method validation for all internal Healthcare Test Methods.