Sr. Quality Systems Program Manager - NMPH - Fridley, MN jobs in United States
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Medtronic · 20 hours ago

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

Medtronic is a global leader in medical technology and solutions, dedicated to championing healthcare access and equity. In this role as the Senior Quality Systems Program Manager, you will lead strategic initiatives to enhance the Neuromodulation and Pelvic Health Quality Management System, focusing on improving customer experience through innovative solutions and managing cross-functional programs to achieve business objectives.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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H1B Sponsor Likelynote

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 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

Qualification

Quality Management SystemLeanSix SigmaRegulatory ComplianceProcess ImprovementProject ManagementCross-functional LeadershipInfluencing SkillsCommunication SkillsPresentation Skills

Required

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

Preferred

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

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)

Company

Medtronic

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Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.

H1B Sponsorship

Medtronic has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)

Funding

Current Stage
Public Company
Total Funding
$18.16B
Key Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B

Leadership Team

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Geoffrey Martha
CEO and Chairman Of The Board Of Directors
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Linnea Burman
SVP & President, Neurovascular
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Company data provided by crunchbase