Supplier Qual Engineer II - CST - Boxborough, MA
About The Position
As a Supplier Quality Engineer II, you will play an integral role in ensuring the quality and reliability of supplier-provided materials, components, and services. You will lead supplier qualification activities, develop and execute risk-based audit plans, and assess supplier performance to ensure compliance with applicable quality and regulatory requirements while supporting continuous improvement initiatives. 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. Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across the globe.
Requirements
- Bachelors degree in Engineering or Technical field with minimum of 2 years of relevant experience, OR Advance degree in Engineering or Technical field with minimum of 0 years of relevant experience
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Nice To Haves
- Experience supporting supplier qualification, supplier audits, supplier development, and supplier performance management within a regulated industry.
- Knowledge of quality management systems and applicable regulatory requirements, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP).
- Experience supporting New Product Development (NPD) activities, including Design Controls, risk management, process validation, and control plan development.
- Proficiency in quality engineering tools and methodologies, including CAPA, root cause analysis, statistical techniques, FMEA, and continuous improvement practices.
- Experience conducting supplier assessments and audits, with the ability to evaluate supplier quality systems and drive corrective actions.
- ASQ certification (CQE, CSQP) and/or Lean Six Sigma Green Belt or Black Belt certification preferred.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Ensure suppliers consistently deliver high-quality parts, materials, 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.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
