Supplier Quality Engineer
Katalyst CRO · Lafayette, CO · 3 wk ago
On-siteQuality AssuranceContract
Responsibilities
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards through supplier assessments, process validation reviews, and evaluation of Production Part Approval Process (PPAP) documentation.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Provides Pre-Market Quality Engineering support to New Product Development (NPD) in partnership with the Component Engineering and Post-Market Supplier Quality Teams to deliver quality parts, materials, and services, prevent defects, and ensure the highest product quality and reliability.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts, implementing strategies for driving product quality and continuous improvement.
- Ensures purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the 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 Test Methods.
- Supports supplier change management activities including manufacturing site transfers, process changes, equipment changes, and material changes through risk assessment, supplier audits, PPAP review, and requalification activities.
Requirements
Bachelor’s degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.214.2(h)(4)(iii)(A)) and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.