Quality Systems Manager - Plymouth, MN

Medtronic; Iowa (LA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with employer match

Paid time off

Employee Stock Purchase Plan

Job summary

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

You will drive CAPA, audits, document control, training, and management review, foster a culture of quality, and support FDA and ISO audits.

Qualifications

• Bachelor’s degree with minimum 5 years relevant experience, or advanced degree with minimum 3 years prior relevant experience.
• 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 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 certifications such as CQE, CQA, CMQ/OE or equivalent.

Responsibilities

• Oversee development and maintenance of quality programs, systems, processes and procedures to ensure compliance with policies and guidelines.
• Provide guidance interpreting policies and regulations to assure compliance.
• Collaborate with operating entities to enforce requirements and meet regulations.
• Lead audit and inspection preparation and coordinate findings resolution with inspectors.
• Prepare reports and documentation (e.g., CAPA) for stakeholders.
• Coordinate legal requests in support of investigations or litigations.
• Maintain and update quality assurance programs and policies.
• Foster uniform standards worldwide and share best practices to support Medtronic’s mission.

Skills

Quality Systems

CAPA

Audits

Regulatory compliance

Cross-functional collaboration

Document control

Continuous improvement

Quality metrics

FDA inspections

ISO 13485

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical field

ASQ certification (CQE, CQA, CMQ/OE) or equivalent

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, ora relatedtechnical 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.
• ASQcertificationsuch 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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail]

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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 accountTuition 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

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, 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.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.