Supplier Qual Engineer II - CST - Boxborough, MA

Job Title: Supplier Quality Engineer II Location: Boxborough, MA (Onsite; 4 days a week) Travel: Approximately 15% travel required. Key Responsibilities Ensure suppliers consistently deliver high‑quality materials, components, and services that meet Medtronic requirements. Qualify and approve suppliers in accordance with company standards and support supplier certification programs to drive quality and cost‑effectiveness. Monitor supplier performance from sourcing through manufacturing, proactively identifying, communicating, and resolving supplier‑related quality issues. Develop, prioritize, and execute supplier audit schedules to ensure compliance with Good Manufacturing Practices (GMP) , quality standards, and regulatory requirements. Assess suppliers’ quality systems, manufacturing processes, and operational performance, providing feedback and recommendations for continuous improvement. Provide Supplier Quality Engineering support for New Product Development (NPD) projects, partnering with Component Engineering and Post‑Market Supplier Quality teams to ensure robust supplier selection and qualification. Drive quality planning and compliance activities throughout the NPD lifecycle, ensuring purchased materials and components meet applicable industry standards, regulatory requirements, and customer expectations. Collaborate with Component Engineers to develop product acceptance sampling strategies, manage Approved Supplier List (ASL) activities, deploy Supplier‑Owned Quality initiatives, and establish control plans for new products. Define Receiving Inspection requirements and support validation of internal Medtronic test methods used to verify supplier‑provided components and materials. Implement strategies that prevent defects, improve supplier performance, and support the delivery of safe, reliable, and high‑quality products to customers. Minimum Qualifications Bachelor’s degree in Engineering or a technical field with a minimum of 2 years of relevant experience, OR advanced degree with no required experience. Experience supporting supplier qualification, audits, development, and performance management within a regulated industry. Knowledge of quality management systems and applicable regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and GMP . Experience supporting NPD activities, including Design Controls, risk management, process validation, and control plan development. Proficiency in quality engineering tools and methodologies: CAPA, root cause analysis, statistical techniques, FMEA, and continuous improvement practices. Experience conducting supplier assessments and audits, with ability to evaluate supplier quality systems and drive corrective actions. ASQ certification (CQE, CSQP) and/or Lean Six Sigma Green/Black Belt certification preferred. For Baccalaureate degrees earned outside the United States, certification that satisfies 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Preferred Qualifications Advanced degree in Engineering or a technical field with no required experience. Specific experience in supplier development and performance management in regulated industries. ASQ or Lean Six Sigma certification. Physical Job Requirements Elective role requiring independent mobility, interaction with a computer, and communication with peers. Reasonable accommodations may be made for individuals with disabilities. EEO Statement Medtronic is an equal opportunity employer and will provide reasonable accommodations for qualified individuals with disabilities. Medtronic will consider qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act. Benefits Health, dental, and vision insurance. Health Savings Account and HRA. Life insurance, long‑term disability. Dependent daycare spending account. Tuition assistance/reimbursement. 401(k) plan with employer match. Short‑term and long‑term disability, paid time off, paid holidays. Employee Stock Purchase Plan, Employee Assistance Program. Incentive plans, MIP. #J-18808-Ljbffr SLD Medtronic Sofamor Danek USA