Supplier Quality Engineer

4 weeks ago

North Haven, United States Tekhawks LLC Full time

Job Description

Job Description

**Only on W2** Job Description: • 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. • 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) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products. • Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to 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. • Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods. • Good Experience in IQ/OQ/PQ processes at manufacturing sites • Quality Engineering/Design or Process Excellence/Lean experience is preferred. • Collaborate to complete Component Qualification, document evidence. • Prepare Protocols, works requests & reports for Supplier Qualified components • Collaborate with suppliers to collect evidence and/or develop Production Part Approval Process (PPAP) • Knowledge in PLMs & ERPs like Wind-chill Required Skills: 1. PPAP 2. PFMEA 3. APQP 4. GMP AND GDP 5. Supplier Quality 6. Risk management 7. CAPA Must Have: Minimum Requirements • Bachelor’s degree required Nice to Have: • Engineering degree is a must • Knowledge in GMP and GDP • Problem solving • CAPA Certification • Led Auditor Certification • Validations knowledge • Strong Statistical Knowledge • Vendor Management experience • Negotiation skills

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