Supplier Quality Engineer

Job Title

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. 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