Senior Supplier Quality Engineer responsible for supplier part qualification, inspection method development, test method validation, and compliance with medical device quality system requirements. Job Requirements Bachelor's degree with 4+ years of relevant experience, or advanced degree with 2+ years of relevant experience. Experience with PPAP part qualification. Experience developing and reviewing control plans. Experience with PFMEA. Experience with IQ, OQ, and PQ documentation. Experience conducting process capability studies. Experience with First Article Inspections. Experience developing inspection methods with suppliers and incoming inspection or metrology teams. Experience validating test and inspection methods. Experience establishing acceptance sampling plans. Experience working within medical device quality system requirements. Preferred Skills Experience with medical device supplier quality engineering. Experience with established medical device quality systems and procedures. Experience supporting supplier qualification and incoming inspection activities. Experience with metrology and dimensional inspection processes. Job Responsibilities Lead PPAP activities for supplier part qualification. Develop and review control plans, PFMEAs, qualification documents, process capability studies, and First Article Inspection documentation. Coordinate with suppliers and incoming inspection teams to establish part acceptance requirements. Develop inspection methods for incoming components and materials. Validate inspection and test methods used for supplier parts. Establish and maintain acceptance sampling plans. Review supplier manufacturing and quality documentation for compliance with applicable requirements. Support supplier qualification and ongoing supplier quality activities. Investigate supplier-related quality issues and support corrective actions. Maintain supplier quality activities in accordance with applicable medical device quality system requirements.

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