Senior Quality Program Manager - NMPH - Rice Creek/Fridley, MN (Onsite)

Medtronic•Fridley, MN

13h•Onsite

About The Position

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. A Day in the Life As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. At Medtronic Neuromodulation (NM) and Pelvic Health (PH) our therapies use advanced stimulation, sensing, software, and digital technologies to restore function and relieve suffering for people living with movement disorders, epilepsy, chronic pain, and pelvic health disorders. Our newest generation of systems can listen directly to neural signals and intelligently adjust therapy in real time — representing a breakthrough era of personalized neuromodulation. In this highly dynamic and rapidly evolving environment, every process and design decision matters, and the quality of our products directly influences clinician confidence, patient outcomes, and global healthcare impact. As the Senior Quality Program Manager, you will play a mission‑critical role at the intersection of innovation and process excellence. You will ensure that products and processes meet customer and regulator expectations global. You will lead high visibility programs to improve products and processes with broad cross-functional and global impact. In this broad, visible, high-impact role, you will: Lead a high-performing program team to execute compliance and product quality improvements for Neuromodulation products. Ensure accountability for program execution, technical excellence, issue identification, escalation, and resolution through cross-functional engagement and governance. Identify and lead issue resolution through the CAPA process, ensuring the highest level of compliance. Present program plans, risks, and progress for leadership review and visibility up to the executive committee level. Serve as a member of the NM and PH Operating Units’ quality leadership team. Lead and communicate key priorities and business strategy to and influence the executive leadership teams of the NM and PH OUs on matters related to business strategy, customer experience, product quality, safety, and compliance. Proactively engage with internal and external stakeholders such as Medtronic Centers of Expertise (COE), FDA, notified bodies, and industry working groups to ensure compliance and maintain alignment with industry best practices.

Requirements

Bachelor’s degree required with a minimum of 7 years of relevant experience within the medical device industry.
OR advance degree with a minimum of 5 years of relevant experience within the medical device industry.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
U.S. work authorization is required for roles below Principal level.

Nice To Haves

Demonstrated experience leading medical device quality systems, compliance, or post market quality teams and programs, including representing outputs in regulator inspections.
Knowledge of global regulatory requirements, including FDA and ISO standards including ISO 13485, ISO 14971 including experience presenting evidence of compliance to regulatory bodies in audits or submission reviews.
Experience in design controls, risk management, CAPA, and quality systems
Experience with design and/or manufacturing transfers
Strong analytical, problem-solving, and decision-making skills.
Experience developing and programmatically implementing quality improvement practices and tools (Design for Six Sigma, DRM, FMEA, FTA, DOE, etc.).

Responsibilities

Lead a high-performing program team to execute compliance and product quality improvements for Neuromodulation products.
Ensure accountability for program execution, technical excellence, issue identification, escalation, and resolution through cross-functional engagement and governance.
Identify and lead issue resolution through the CAPA process, ensuring the highest level of compliance.
Present program plans, risks, and progress for leadership review and visibility up to the executive committee level.
Serve as a member of the NM and PH Operating Units’ quality leadership team.
Lead and communicate key priorities and business strategy to and influence the executive leadership teams of the NM and PH OUs on matters related to business strategy, customer experience, product quality, safety, and compliance.
Proactively engage with internal and external stakeholders such as Medtronic Centers of Expertise (COE), FDA, notified bodies, and industry working groups to ensure compliance and maintain alignment with industry best practices.

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)