Quality Engineer – Manufacturing (Medical Device)

Quality Engineer – Manufacturing (Medical Device)Location: Shakopee, MN Job Type: Contract‑to‑HireJob OverviewWe are seeking a Quality Engineer to support a manufacturing environment serving medical device customers. This role is hands‑on and customer‑facing, focused on quality engineering execution, continuous improvement, and compliance within a regulated production setting. The ideal candidate brings experience with ISO 9001, strong problem‑solving skills, and the ability to work cross‑functionally with manufacturing, engineering, and customers.Key ResponsibilitiesWork directly with customers to address quality concerns, complaints, returns, and change requestsCreate, update, and maintain PFMEAs, control plans, and work instructionsTroubleshoot and analyze internal manufacturing failures and nonconformancesLead and support corrective actions (CAPA) and MRB activitiesAssist with testing and validation activitiesCreate and document quality records, including Major Quality Miscue (MQM) formsAnalyze and report production and test data to identify trends and improvement opportunitiesPerform and support random inspections using standard inspection equipment (calipers, micrometers, etc.)Coordinate closely with manufacturing, engineering, and other internal teamsSupport continuous improvement initiatives to enhance product quality and reduce defectsFollow all safety requirements and maintain a clean, organized work areaQualificationsBachelor’s degree in Engineering or a related technical field3+ years of experience in a manufacturing quality engineering roleExperience supporting medical device or regulated manufacturing environments preferredWorking knowledge of ISO 9001 Quality Management SystemsHands‑on experience with PFMEA, control plans, MRB, CAPA, SPC, and root cause analysisFamiliarity with ERP systems (SAP or similar preferred)Ability to read and interpret engineering drawings and technical documentationStrong written and verbal communication skillsDetail‑oriented, organized, and able to manage multiple prioritiesWork EnvironmentPrimarily office‑based with regular interaction on the manufacturing floorOccasional travel to customer or vendor sites