BS degree in engineering or technical field with minimum of 8 years of relevant experience. Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. Experience in global supplier management and supplier quality engineering role strongly desired. Communicates effectively and concisely packages up information to deliver key points; appropriately scales communication style and depth according to the audience. Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing. Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors. Ability to work independently and collaborate with project teams; organized and self-driven. ISO 13485 lead auditor of quality systems experience. Strong knowledge of FDA 21 CFR 820 and EU MDR. Ability to travel up to 10% of the time. Chemical Engineering, Materials Engineering, Mechanical Engineering, background preferred Experience in working with chemical, injection molding, Resins or extrusion component suppliers Quality Engineer / Supplier Quality Engineer certifications Experience with manufacturing support or process development Experience with auditing quality systems or ISO13485, 9001, TS16949 standards Experience in lean and six sigma methodologies Experience with project management
Supplier Engineer • Arden Hills, Minnesota, United States