Supplier Quality Engineer

Engineering, Technical, or Scientific discipline with minimum of 5-8 years of related experience is required, preferably within a regulated environment (e.g. FDA regulated). Good Experience in IQ / OQ / PQ processes at Mfg sites. Quality Engineering/Design or Process Excellence/Lean experience is preferred. Responsibilities include: 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 of the QSR, Design Controls, and ISO quality requirements. Experience conducting Process / Design Failure Mode Effects and Analysis. Understand and interpret all manufacturing audits, including ISO 13485 and other industry standards. Conduct supplier quality control audits on a regular basis to ensure vendors and their supplies remain in compliance with company and federal manufacturing and production standards. Experience in CAPA execution and Non-Conformance management. Very Good in Oral & Written Communication. Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing). ASQ certifications are an asset. Mechanical product knowledge is preferred. Problem-solving techniques including 8D, root cause analysis, and cause and effect analysis. Knowledge in PLMs & ERPs like WindChill, ADAPTIV, AGILE, JDE, SAP.

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