Quality Engineering Manager

Medtronic • Grand Rapids, MI

23h

About The Position

This position leads the quality engineering team, ensuring products and processes meet regulatory standards and Medtronic’s quality expectations. The role involves overseeing quality initiatives, supporting compliance, and driving continuous improvement across engineering and manufacturing operations. The manager will also manage and mentor a team of quality engineers, providing guidance, training, and performance feedback. Key responsibilities include overseeing the development, implementation, and maintenance of quality systems and processes in accordance with regulatory requirements such as GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR, and SOTA. The manager will lead investigations and resolutions for product quality issues, complaints, non-conformances, and CAPA, collaborating with engineering and manufacturing functions. The role is responsible for finished medical devices within the Cardiac Surgery Business Unit, supporting manufacturing operations and ensuring compliance with specifications and customer requirements. It also involves ensuring robust risk management and validation strategies using tools like PHA and PFMEA, and coaching the use of process improvement tools (DMAIC, RCA, 5 Whys, Fishbone, cause mapping) and statistical analysis tools (DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, TMV). The manager will oversee V&V protocols (IQ, OQ, PQ), utilize analytical tools like Minitab and Power BI, and manage product lifecycle management efforts, including quality systems and technical documentation. Additionally, the role involves mentoring candidates for First Time Quality (FTQ) Level 1 certification and contributing to enterprise-wide FTQ initiatives.

Requirements

• Bachelor’s degree or foreign equivalent in Biomedical, Mechanical, Industrial Engineering or related engineering field and five (5) years of experience as a Quality Engineer or related occupation in medical device industry; or Master’s degree or foreign equivalent in Biomedical, Mechanical, Industrial Engineering or related engineering field and three (3) years of experience as a Quality Engineer or related occupation in medical device industry.
• At least three (3) years’ experience with GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR, and SOTA.
• At least three (3) years’ experience with Risk Assessments, PHA, and PFMEA.
• At least three (3) years’ experience with Non-Conformances and CAPA.
• At least three (3) years’ experience with DMAIC, RCA, 5 Whys, Fishbone, and cause mapping.
• At least three (3) years’ experience with DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV.
• At least three (3) years’ experience with V&V protocols and IQ/OQ/PQ.
• At least three (3) years’ experience with Minitab and Power BI.
• At least three (3) years’ experience with Product lifecycle mgmt., including quality systems and authoring technical documentation.
• At least three (3) years’ experience with FTQ principles.
• At least three (3) years’ experience with Cardiac surgery devices.

Responsibilities

• Lead the quality engineering team, ensuring that products and processes meet regulatory standards and Medtronic’s quality expectations.
• Oversee quality initiatives, support compliance, and drive continuous improvement across engineering and manufacturing operations.
• Manage and mentor a team of quality engineers, providing guidance, training, and performance feedback.
• Oversee the development, implementation, and maintenance of quality systems and processes in accordance regulatory requirements including Good Manufacturing Practices (GMP) standards, 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State of the Art (SOTA).
• Lead investigation and resolution of product quality issues and complaints, non-conformances, and CAPA (Corrective and Preventive Actions).
• Lead collaboration with engineering and manufacturing functions to investigate and resolve quality or compliance issues discovered during operations.
• Responsible for products in the form of finished medical devices within the Cardiac Surgery Business Unit by supporting manufacturing operations, evaluating compliance of materials and processes with specifications, and customer requirements in compliance.
• Lead Quality Engineering team for medical device components, ensuring that all finished good, and processes meet specifications.
• Ensure robust risk management and validation strategies are applied to products and processes, leveraging knowledge in Preliminary Hazard Analysis (PHA), and Process Failure Modes and Effects Analysis (PFMEA).
• Coach the use of Process Improvement tools, including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis (RCA), 5 Whys, Fishbone, and cause mapping.
• Coach and lead Design of Experiments (DOE) methods for process development and statistical analysis tools for process capability (Cpk/Ppk), ANOVA, Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV).
• Oversee V&V (verification and validation) protocols, including Installation Qualification, Operational Qualification, Performance Qualification (IQ, OQ, and PQ).
• Utilize analytical tools including Minitab and Power BI for statistical analysis and data-driven decision-making.
• Manage product lifecycle mgmt. efforts, including overseeing quality systems and authoring technical documentation.
• Mentor and coach candidates pursuing First Time Quality (FTQ) Level 1 certification and provide strategic guidance for Level 1 and Level 2 Coach certification.
• Contribute to enterprise-wide FTQ initiatives and support multiple application areas to drive quality excellence.

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)
• Paid sick time (for temporary employees, as required under applicable state law)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees