Manufacturing Quality Engineer

Job Title: Manufacturing Quality Engineer - Medical DeviceDuration: 9+ Months (Possible extension)Location: Arden Hills, MN 55112Hybrid RoleResponsibilities:The Supplier QA Engineer will play a key part in leading performance improvement of suppliers and increasing the suppliers' capabilities to consistently meet client's requirements.Will support Global Sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projectsDrives improvement and corrective actions in the quality of components sourced from outside suppliers.Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, R&DDevelops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.Plans and organizes non-routine tasks with approval.Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedulesEstablishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers.Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.Education/Experience:BS degree in an Engineering related field, such as: Mechanical Engineering, Materials Engineering, Chemical Engineering, Electrical Engineering, or similar technical degree with 2-3 years related experience.Experience in Quality Management Systems, regulatory compliance, and risk management.People with Med device QMS preferred or experience working with Manufacturing.Experience with problem solving quality tools, Corrective/Preventive Actions (CAPA), Technical DocumentationPreferred Qualifications:Experience with or lead auditor certification to ISO 13485, 9001, TS 16949 standards

Created: 2025-10-02