Medtronic
Sr. Quality Systems Program Manager - NMPH - Fridley, MN
Medtronic, Fridley, Minnesota, United States
Overview
We anticipate the application window for this opening will close on 3 Oct 2025. 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. Careers That Change Lives
In this exciting role as the
Senior Quality Systems Program Manager , you will lead strategic initiatives to improve the Neuromodulation and Pelvic Health Quality Management System (QMS), focusing on enhancing customer experience through innovative solutions. Additionally, this role will lead other cross-functional programs and initiatives to achieve key business objectives. Responsibilities
Lead integration of new product lines into the Neuromodulation and Pelvic Health QMS ensuring alignment with business objectives and compliance requirements. Drive the development and implementation of the next-generation QMS toolset to improve user experience and engagement within the Quality System. Plan, execute, and manage process improvement initiatives using Lean and Six Sigma. Evaluate existing processes, identify improvement opportunities, and develop metrics to measure performance and success. Provide oversight for the development and maintenance of quality programs, systems, processes and procedures to ensure compliance with policies and that performance and quality of services conform to standards. Provide expertise in interpreting policies and regulatory requirements to assure compliance. Lead audit and inspection preparation, resolution of findings, and liaise with auditing groups and inspectors. Prepare reports and documentation (e.g., Corrective and Preventive Actions) for stakeholders. Coordinate legal requests in support of government investigations or litigations. Ensure quality assurance programs and policies are maintained and updated. Facilitate uniform standards worldwide and enable best practice sharing to support the company's global mission. Location
Fridley, MN (ONSITE). Travel
Ability to travel up to 10%. Must Have (Minimum Requirements)
Bachelor’s degree with a minimum of 7 years in Quality Systems within the medical device industry, or an advanced degree with a minimum of 5 years in Quality Systems within the medical device industry. Nice to Have (Preferred Qualifications)
Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation. Experience leading projects and programs from ideation to implementation. Experience leading cross-functional project teams and managing complex programs with competing priorities. Expertise in Lean, Six Sigma, or other process improvement methodologies. Ability to influence across functions and levels, including senior leadership and external stakeholders. Strong communication and presentation skills, with the ability to simplify complex information for diverse audiences. Physical Job Requirements
The physical demands described are representative of those that must be met to perform the essential functions. Reasonable accommodations may be made for individuals with disabilities. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. locations: $149,600.00 - $224,400.00. This position is eligible for the Medtronic Incentive Plan (MIP). Regular employees may have access to health, dental, vision insurance, 401(k) with employer match, paid time off, holidays, and more as described in the benefits plan. Further details are available at the Medtronic benefits and compensation plans page. About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people. Learn more about our business, mission, and commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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We anticipate the application window for this opening will close on 3 Oct 2025. 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. Careers That Change Lives
In this exciting role as the
Senior Quality Systems Program Manager , you will lead strategic initiatives to improve the Neuromodulation and Pelvic Health Quality Management System (QMS), focusing on enhancing customer experience through innovative solutions. Additionally, this role will lead other cross-functional programs and initiatives to achieve key business objectives. Responsibilities
Lead integration of new product lines into the Neuromodulation and Pelvic Health QMS ensuring alignment with business objectives and compliance requirements. Drive the development and implementation of the next-generation QMS toolset to improve user experience and engagement within the Quality System. Plan, execute, and manage process improvement initiatives using Lean and Six Sigma. Evaluate existing processes, identify improvement opportunities, and develop metrics to measure performance and success. Provide oversight for the development and maintenance of quality programs, systems, processes and procedures to ensure compliance with policies and that performance and quality of services conform to standards. Provide expertise in interpreting policies and regulatory requirements to assure compliance. Lead audit and inspection preparation, resolution of findings, and liaise with auditing groups and inspectors. Prepare reports and documentation (e.g., Corrective and Preventive Actions) for stakeholders. Coordinate legal requests in support of government investigations or litigations. Ensure quality assurance programs and policies are maintained and updated. Facilitate uniform standards worldwide and enable best practice sharing to support the company's global mission. Location
Fridley, MN (ONSITE). Travel
Ability to travel up to 10%. Must Have (Minimum Requirements)
Bachelor’s degree with a minimum of 7 years in Quality Systems within the medical device industry, or an advanced degree with a minimum of 5 years in Quality Systems within the medical device industry. Nice to Have (Preferred Qualifications)
Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation. Experience leading projects and programs from ideation to implementation. Experience leading cross-functional project teams and managing complex programs with competing priorities. Expertise in Lean, Six Sigma, or other process improvement methodologies. Ability to influence across functions and levels, including senior leadership and external stakeholders. Strong communication and presentation skills, with the ability to simplify complex information for diverse audiences. Physical Job Requirements
The physical demands described are representative of those that must be met to perform the essential functions. Reasonable accommodations may be made for individuals with disabilities. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. locations: $149,600.00 - $224,400.00. This position is eligible for the Medtronic Incentive Plan (MIP). Regular employees may have access to health, dental, vision insurance, 401(k) with employer match, paid time off, holidays, and more as described in the benefits plan. Further details are available at the Medtronic benefits and compensation plans page. About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people. Learn more about our business, mission, and commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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