Quality Engineering Manager

Medtronic•Grand Rapids, MI

7h•$150,000 - $211,200

About The Position

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. Relocation assistance not available for this position. #LI-DNI.

Requirements

Requires a 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.
Must possess at least three (3) years’ experience with each of the following: GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR, and SOTA; Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA; DMAIC, RCA, 5 Whys, Fishbone, and cause mapping; DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; V&V protocols and IQ/OQ/PQ; Minitab and Power BI; Product lifecycle mgmt., including quality systems and authoring technical documentation; FTQ principles; and Cardiac surgery devices.

Responsibilities

Lead the quality engineering team
Oversee quality initiatives
Support compliance
Drive continuous improvement across engineering and manufacturing operations
Manage and mentor a team of quality engineers
Oversee the development, implementation, and maintenance of quality systems and processes
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
Responsible for products in the form of finished medical devices within the Cardiac Surgery Business Unit
Lead Quality Engineering team for medical device components
Ensure robust risk management and validation strategies are applied to products and processes
Coach the use of Process Improvement tools
Coach and lead Design of Experiments (DOE) methods for process development and statistical analysis tools
Oversee V&V (verification and validation) protocols
Utilize analytical tools including Minitab and Power BI for statistical analysis and data-driven decision-making
Manage product lifecycle mgmt. efforts
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)