Jobs · Quality Assurance · Minnesota

Supplier Quality Engineer with Medical Device

Global Business Ser. 4u · Minneapolis, MN · 2 wk ago
Quality AssuranceFull-time
Contract Location: Plymouth, MN Job Description Bring 5+ years of manufacturing engineering experience, preferably within the medical device or other highly regulated industries.Apply strong Supplier Quality Engineering (SQE) and Receiving Inspection experience while working directly with suppliers and utilizing quality tools.Use SAP supply chain/quality modules or similar ERP systems to support manufacturing, supplier, and quality processes.Work with Windchill or other PLM/document control systems to manage engineering changes, change orders, BOM updates, and controlled documentation.Create, maintain, and improve inspection procedures, including developing or sourcing appropriate inspection tools and equipment.Support component specifications, testing, qualification, and approval to ensure components meet quality and performance requirements.Collaborate closely with Design Engineering on component selection, quality, reliability, and manufacturability.Analyze incoming material defects and nonconformances, identify root causes, and communicate quality issues to suppliers.Review product and component designs for quality, manufacturability, reliability, and production readiness.Investigate supplier-related field failures, conduct root-cause analysis, and lead corrective and preventive actions.Ensure manufacturing and supplier quality activities comply with applicable FDA, GMP, ISO 13485, and ISO 14971 requirements.Partner with cross-functional teams and suppliers to drive continuous improvement, corrective actions, quality compliance, and reliable component performance.

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