Supplier Qual Engineer I.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life In this exciting role as a Supplier Quality Engineer I, you will be responsible for supporting the oversight of manufacturing which occurs at the Medtronic strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs), with accountability to support changes to existing supplied products and processes, as well as oversight of nonconformances and complaint investigations performed by the suppliers. While partnering with our CMs and OEMs, including sub-tier suppliers as required, this position is responsible for maintaining necessary controls and drive improvements relating to finished medical device / component quality in conjunction and within our suppliers’ quality management systems. You will work in partnership with the internal Medtronic R&D, Quality, and Regulatory teams, primarily in the Cranial & Spinal Technologies operating unit, to ensure our supplied products conform to finished device requirements, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. A Day in the Life Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented. Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes). Lead quality process improvements and streamlining activities. Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes); leveraging the Production Part Approval Process (PPAP) when required. Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality. Drive resolution of all issues raised during testing/qualification. Manages Nonconformances from investigation through disposition in collaboration with suppliers and internal Medtronic partners. Ensure appropriate rigor in responses to Medtronic customer complaints, including oversight of Supplier investigation into the allegation Supports Corporate and external (FDA, TUV, BSI, etc.) quality and compliance audits of the CM/OEM products and/or the supplier’s Quality Management System. Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements. Support / Lead sustaining engineering projects that may involve manufacturing process transfers, label/IFU updates, sub-supplier qualification, performance testing (verification and validation), and design qualification. Participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements. Nice to Have (Preferred Qualifications) Bachelor’s degree in Engineering, Science, or technical field with 2 years’ experience in Medical Device and/or Capital Equipment OR Advanced degree in Engineer ... (truncated, view full listing at source)