| Location | Minneapolis, MN |
Overview We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality initiatives.Responsibilities Drive supplier quality and incoming inspection activitiesAnalyze material non-conformances and work directly with suppliers on resolutionSupport component selection, qualification, and reliability assessmentsReview product designs for quality and manufacturabilityLead supplier investigations, root cause analysis, and corrective actionsEducation & Experience 5+ years of experience in Manufacturing Engineering, Supplier Quality, or Quality Engineering within Medical DevicesHands-on experience with Supplier Quality Engineering, Receiving Inspection, and supplier managementExperience with SAP (Quality/Supply Chain modules) or similar ERP systemsKnowledge of Windchill or other document control systems for change management and BOM updatesExperience developing inspection procedures, quality plans, and inspection toolingAbility to support component qualification, testing, validation, and approval activitiesStrong collaboration with Design Engineering on component quality, reliability, and manufacturabilityExperience investigating supplier-related quality issues, material defects, and corrective actions (CAPA)Knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971#J-18808-Ljbffr