Supplier Quality Engineer II

Medtronic • Billerica, MA

9d • $80,000 - $120,000 • Onsite

About The Position

As a Supplier Quality Engineer II, you'll play a key role in ensuring our suppliers consistently deliver high-quality materials, components, and services that support the manufacturing of innovative medical devices. Working collaboratively across Supplier Quality, Component Engineering, Manufacturing, Operations, and New Product Development, you'll help drive supplier performance, strengthen quality systems, and support the successful launch of new products in a highly regulated environment. This position is ideal for an engineer who enjoys partnering with suppliers, solving technical challenges, analyzing data, and driving continuous improvement while making a meaningful impact on patient outcomes. This is a fully onsite position based in Billerica, MA, where in-person collaboration is essential to supporting our manufacturing operations and delivering life-changing therapies.

Requirements

• Bachelors degree with a minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience

Nice To Haves

• Experience interpreting engineering drawings, specifications, and technical documentation.
• Strong analytical and problem-solving skills with the ability to investigate complex quality issues.
• Excellent communication and collaboration skills with the ability to build strong relationships across internal teams and external suppliers.
• Experience working within a regulated manufacturing environment such as medical devices, pharmaceuticals, biotechnology, aerospace, automotive, or another highly regulated industry.
• Knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 9001, or similar quality standards.
• Experience conducting supplier audits or supporting supplier quality improvement initiatives.
• Familiarity with quality tools such as DAMIC, CAPA, FMEA, SPC, Control Plans, PPAP, MSA, Root Cause Analysis, 8D, or Six Sigma methodologies.
• Experience supporting supplier quality activities during New Product Development (NPD).
• ASQ Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or similar certification is a plus.
• Ability to manage multiple priorities while maintaining strong attention to detail.

Responsibilities

• Partner with suppliers to ensure the consistent delivery of high-quality parts, materials, and services that meet Medtronic quality standards.
• Monitor supplier performance throughout the product lifecycle, proactively identifying, investigating, and resolving supplier quality issues.
• Support supplier qualification, approval, and ongoing performance management activities in accordance with company procedures and regulatory requirements.
• Develop, prioritize, and execute supplier audit plans to assess compliance with Good Manufacturing Practices (GMP), quality system requirements, and applicable industry standards.
• Evaluate supplier quality systems and manufacturing processes, providing constructive feedback and partnering on continuous improvement initiatives.
• Analyze supplier quality data, identify trends, and implement corrective and preventive actions to improve supplier performance.
• Collaborate with cross-functional teams including Manufacturing, Engineering, Operations, Regulatory Affairs, and Supply Chain to address supplier-related quality concerns.
• Participate in root cause investigations, supplier corrective action requests (SCARs), and verification of implemented solutions.
• Support supplier risk management activities and ensure compliance with applicable regulatory and quality system requirements.
• Partner with New Product Development (NPD), Component Engineering, and Post-Market Supplier Quality teams to support the successful introduction of new products.
• Provide Supplier Quality engineering support throughout the product development lifecycle to ensure new components and suppliers meet quality, reliability, and regulatory requirements.
• Collaborate with Component Engineers to develop product acceptance sampling strategies, supplier qualification plans, and control plans for new products.
• Support Approved Supplier List (ASL) activities and Supplier-Owned Quality initiatives.
• Define Receiving Inspection requirements and support validation of internal inspection and test methods where required.
• Help establish robust quality controls that prevent defects and support successful product commercialization.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level