Supplier Quality Engineer

2 weeks ago

Mounds View, United States Katalyst HealthCares & Life Sciences Full time

Summary:We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualification, PPAP documentation, and process validation. This role is critical in ensuring that suppliers meet Healthcare's quality standards and regulatory requirements. Roles & Responsibilities: Qualify suppliers in accordance with company standards. Manage and maintain the Approved Supplier List (ASL) in compliance with Healthcare's purchasing control procedures. Manage and release all PPAP deliverables including Control Plans, MSA, PFMEA, FAI, etc., within the document control system. Support PPAP execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies. Define Receiving Inspection requirements. Validate test methods in alignment with internal Healthcare procedures. Work with cross-functional teams to develop and implement product acceptance sampling strategies. Deploy supplier quality tools such as PFMEA, MSA, control plans for both new and legacy products. Provide technical assistance to suppliers throughout the product/process qualification lifecycle. Ensure delivery of high-quality parts, materials, and services to prevent defects and support Healthcare's commitment to reliability. Collaborate with suppliers to address SCAPA/Client issues in compliance with company standards. Education & Experience: Bachelor's degree in Engineering or related field. Minimum + years of experience in supplier quality engineering within the medical device industry. ISO Certified Talent preferred by client. Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO standards. Excellent communication and problem-solving skills. Ability to work independently and in cross-functional teams.

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