Supplier Qual Engineer II - CST - Boxborough, MA
About The Position
As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. 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. 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.
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
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
