Quality Engineer I

Medtronic • Danvers, MA

1d

About The Position

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 role, you’ll contribute to cross-functional efforts and continuous improvement in a dynamic, collaborative environment, and will provide comprehensive manufacturing quality support throughout the production process. As a Quality Engineer I, you will: Support product and process quality for Class II/III medical devices in a regulated manufacturing environment Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis Perform risk assessments and support risk management documentation (FMEA, fault tree analysis) Provide quality engineering support for process improvements and product launches Review and approve validations, protocols, and test methods (IQ/OQ/PQ, MSA, etc.) Analyze quality trends, monitor metrics, and recommend data-driven actions Collaborate across functions (R&D, Manufacturing, Regulatory, and Supplier Quality) to ensure compliance and product integrity Support audits and inspections (internal, supplier, and regulatory bodies) Contribute to fostering a culture of inclusion, safety, and continuous learning

Requirements

• Bachelors degree and 0 years relevant experience

Nice To Haves

• 1+ years of relevant quality, manufacturing, or product development experience in a regulated industry (medical device preferred)
• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and quality systems
• Strong analytical, problem-solving, and effective communication skills
• Strong interpersonal and influencing skills
• Experience with CAPA, risk management tools, and statistical analysis
• Lean, Six Sigma, or quality certifications (e.g., ASQ CQE)
• Hands-on knowledge of root cause investigation and validation protocols
• Experience working in an inclusive, cross-functional team setting

Responsibilities

• Support product and process quality for Class II/III medical devices in a regulated manufacturing environment
• Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis
• Perform risk assessments and support risk management documentation (FMEA, fault tree analysis)
• Provide quality engineering support for process improvements and product launches
• Review and approve validations, protocols, and test methods (IQ/OQ/PQ, MSA, etc.)
• Analyze quality trends, monitor metrics, and recommend data-driven actions
• Collaborate across functions (R&D, Manufacturing, Regulatory, and Supplier Quality) to ensure compliance and product integrity
• Support audits and inspections (internal, supplier, and regulatory bodies)
• Contribute to fostering a culture of inclusion, safety, and continuous learning

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
• Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

What This Job Offers

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