Jobs · Quality Assurance · Colorado

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.

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