Quality Systems Director (QMS), Plymouth, MN

Medtronic; Plymouth (MN); On-site; USD 184,000 - 276,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) plan with employer match

Tuition assistance/reimbursement

Paid time off

Job summary

Medtronic seeks a Quality Director to lead the QMS and quality strategy for the PVH OU, including FDA inspection readiness and due diligence for acquisitions. This onsite role is based in Plymouth, MN with design and manufacturing sites in Minneapolis, Galway, Tijuana, Danvers, and Irvine.

The director will establish top-down quality KPIs, align OKRs with business objectives, and collaborate with cross-functional teams to strengthen regulatory compliance and operational effectiveness.

Qualifications

• Must have Baccalaureate with extensive managerial experience.
• Experience interacting with FDA during audits is preferred.
• Strong leadership and cross-functional collaboration required.

Responsibilities

• Lead the QMS and quality strategy for the PVH OU and oversee inspections.
• Drive quality KPIs and align OKRs with enterprise objectives.
• Participate in quality due diligence for acquisitions and integration planning.
• Collaborate with manufacturing sites to improve regulatory compliance.

Skills

FDA experience

QMSR experience

Leadership

Interpersonal skills

Project/program management

Quality orientation

Patient focus

Education

Bachelor's degree + 10+ yrs exp with 7+ mgr yrs

Advanced degree + 8+ yrs exp with 7+ mgr yrs

Job description

We anticipate the application window for this opening will close on - 13 Aug 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 Director will lead the Quality Management System (QMS) and overall quality strategy for the PVH Operating Unit (OU), while also providing strategic quality leadership for acquisitions and divestitures. This role will oversee QMS activities through a dotted-line team structure and be responsible for preparing the organization for FDA QMSR inspections, including leading FDA front-room inspection activities.

The PVH OU includes a design center and manufacturing sites located in Minneapolis, Galway, Tijuana, and Danvers, with cross-functional collaboration extending to Irvine. In addition, the Director will drive the quality strategy for the PCH OU by establishing top-down quality KPIs and aligning bottom-up operational strategies and OKRs to support business objectives.

The Director will also play a key role in mergers and acquisitions by participating in quality due diligence for potential acquisitions, assessing quality systems and compliance risks, and supporting integration planning, cost modeling, and post-acquisition quality integration efforts. This is an onsite position based in Plymouth, MN

Primary Responsibilities:

• Support quality duediligence, integrationplanning, and executionactivities for acquisitionsand business integrations.
• Develop and leadthe overall qualitystrategy and organizationalObjectives and KeyResults (OKRs), aligningenterprise, operating unit, and functional priorities.
• Serve as theQuality Management System(QMS) leader, establishingand executing strategiesto ensure FDAinspection readiness, includingcompliance with QualityManagement System Regulation(QMSR) requirements.
• Act as thefront-room leaderduring FDA inspectionsand support otherregulatory inspectionsat the Minneapolissite as needed.
• Partner with andprovide guidance tothe PVH manufacturingfacility on QualityManagement System initiatives, regulatory compliance,and quality bestpractices.
• Collaborate closely withthe existing QMSsupport team responsiblefor Quality ManagementReview (QMR), KeyPerformance Indicators(KPIs), Corrective andPreventive Actions (CAPA), and other qualitysystem processes.
• Drive continuous improvementinitiatives to strengthenquality systems, regulatorycompliance, and operationaleffectiveness.
• Build strong relationshipswith cross-functionalstakeholders to ensureconsistent implementationof quality standardsand regulatory expectations.

Must Have: Minimum Requirements- To be considered for this role, please ensure the minimum requirements are evident in your applicant profile:

• Baccalaureatewith minimum of 10+ years of experience with 7 years of managerial experience OR advanced degree with a minimum of 8 years prior relevant experience, with 7 years of managerial experience.

Nice to Have:

• FDA experience: A demonstrated ability to interacted with FDA during audits/ questions
• QualityManagement System Regulation(QMSR) experience is preferred.
• Leadership: A demonstrated ability to collaborate with mfg sites to reduce the overall compliance gaps
• Excellent interpersonal and communication skills.
• Excellent project and program management skills.
• Quality orientation and patient focus.

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements 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. (ADA-United States of America).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. Learn more about our benefits here.

LTI Eligible: This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. Base pay is based on numerous factors and may vary depending on job-relatedknowledge, skills, and experience.

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):$184,000.00 - $276,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

This position is eligible for an annual long-term incentive plan.

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

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.