Sr. Quality Systems Program Manager - NMPH - Fridley, MN

Medtronic-posted 3 days ago
Full-time • Mid Level
Onsite • Fridley, MN
5,001-10,000 employees
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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 Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 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.

  • 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 methodologies such as Lean and Six Sigma.
  • Evaluate existing processes, identify improvement opportunities, and develop metrics to measure performance and success.
  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Bachelor’s degree required with a minimum of 7 years in Quality Systems within the medical device industry.
  • OR advance degree with a minimum of 5 years of in Quality Systems within the medical device industry.
  • 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.
  • Demonstrated 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.
  • Demonstrated 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.
  • Medtronic offers a competitive Salary and flexible Benefits Package
  • We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
  • 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).
  • 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).
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