Quality Systems Manager - Plymouth, MN

COV Covidien LP; Plymouth (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with employer match

Paid time off

Tuition assistance/reimbursement

Employee Stock Purchase Plan

Employee Assistance Program

Job summary

Medtronic in Plymouth, Minnesota seeks a Quality Systems Manager to lead the Quality Management System at the Nathan Lane site. You will collaborate with Operations, Quality, Manufacturing Engineering, Regulatory, and Supply Chain to ensure compliant, effective quality systems that scale with the business.

The role emphasizes CAPA, document control, training, audits, and management review while advancing Medtronic's mission to alleviate pain, restore health, and extend life.

Qualifications

• Bachelor's degree with 5+ years relevant experience, or advanced degree with 3+ years prior relevant experience.
• Experience supporting FDA inspections, ISO 13485 audits, MDSAP audits, customer audits, or internal quality audits.
• ASQ certification such as CQE, CQA, CMQ/OE, or equivalent.
• Experience partnering with Manufacturing, Operations, Engineering, Regulatory Affairs, or Supply Chain.

Responsibilities

• Oversight for quality programs, systems, processes ensuring compliance with policies and standards.
• Guidance interpreting policies and regulations to assure compliance.
• Lead audit/preparation and coordinate with inspectors through all stages.
• Prepare reports and documentation for stakeholders, including CAPAs.
• Drive uniform global standards and share best practices to support the mission.

Skills

Quality management

Regulatory compliance

Auditing

Cross-functional collaboration

CAPA leadership

Education

Bachelor's in Engineering/Quality/Life Sciences

ASQ CQE/CQA/CMQOE

Job description

We anticipate the application window for this opening will close on - 28 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Quality Systems Manager provides leadership for the Quality Management System (QMS) at Medtronic's Nathan Lane manufacturing site in Plymouth, Minnesota. Supporting the production of life-changing medical technologies within the Peripheral Vascular Health portfolio, this site is a high-volume, highly regulated manufacturing operation focused on delivering safe, effective, and reliable products to patients around the world. In this role, you will partner closely with Operations, Quality, Manufacturing Engineering, Supply Chain, and Regulatory partners to ensure quality systems remain compliant, effective, and aligned with business objectives. As a key member of the site quality organization, the Quality Systems Manager will lead continuous improvement initiatives across core quality system processes, including compliance, audits, CAPA, document control, training, and management review activities. This leader will drive a culture of quality and operational excellence, ensuring regulatory requirements are met while enabling the business to scale, innovate, and continuously improve. The role requires strong cross-functional collaboration, sound decision-making, and the ability to influence stakeholders at all levels while advancing Medtronic's Mission to alleviate pain, restore health, and extend life. 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 5 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.

Responsibilities may include the following and other duties may be assigned.

• 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.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads 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.

Required Qualifications

Bachelor's degree with a minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

Preferred Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
• Experience supporting Quality Management System (QMS) processes, including CAPA, nonconformance, change control, document control, training, or management review.
• Experience supporting FDA inspections, ISO 13485 audits, MDSAP audits, customer audits, or internal quality audits.
• Experience interpreting and applying FDA Quality System Regulation, ISO 13485, MDSAP, or other regulated quality system requirements.
• Experience supporting quality systems within the medical device, pharmaceutical, biotechnology, or other regulated industries.
• Experience partnering with Manufacturing, Operations, Engineering, Regulatory Affairs, or Supply Chain functions.
• Experience developing, monitoring, or reporting quality system metrics.
• Experience supporting quality systems in a manufacturing environment.
• Experience leading quality, compliance, audit, or continuous improvement projects.
• ASQ certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• 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)

The following benefits and additional compensation are available to all regular employees:

• 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)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans

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. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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 federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

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