Key skills
CRBIPower BIStatistical AnalysisRisk ManagementCollaboration
About this role
Position Description:
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.
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
Basic Qualifications:
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.
The position is located at Medtronic, Inc., 620 Watson Street SW, Grand Rapids, MI 49504.
Salary: $150,000 to $211,200 per year
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).
The following benefits and additional compensation are available to all regular employees: 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. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Use this link to hyperlink
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic
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.
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
Basic Qualifications:
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.
The position is located at Medtronic, Inc., 620 Watson Street SW, Grand Rapids, MI 49504.
Salary: $150,000 to $211,200 per year
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).
The following benefits and additional compensation are available to all regular employees: 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. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Use this link to hyperlink
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic