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

Fridley, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree with a minimum of 7 years in Quality Systems within the medical device industry
OR Advanced degree with a minimum of 5 years in Quality Systems within the medical device industry
Ability to travel up to 10%
ONSITE position in Fridley, Minnesota

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
Provide 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
Provide 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 liaise with auditing groups and inspectors through all stages of the audits
Prepare reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external
Coordinate legal requests in support of government investigations or litigations
Ensure the quality assurance programs and policies are maintained and modified regularly
Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally
Lead strategic initiatives to improve the Neuromodulation and Pelvic Health Quality Management System (QMS), focusing on enhancing customer experience through innovative solutions
Lead other cross-functional programs and initiatives to achieve key business objectives

Skills

Quality Management System

Lean

Six Sigma

Process Improvement

Program Management

Compliance

Metrics Development

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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