Quality Engineering Manager

Position Description:

Lead the quality engineering team ensuring that products and processes meet regulatory standards and Medtronics 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.

Basic Qualifications:

Requires a Bachelors 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 Masters 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.

Salary: $150000 to $211200 per year

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans