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Quality Systems Program Director (QMS), Plymouth, MN

Medtronic · Plymouth, MN · Today
On-siteInformation Technology$184k–$276k/yrFull-time

We anticipate the application window for this opening will close on 14 Aug 2026.

About the role

The Quality Program 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.

Responsibilities

  • Support quality due diligence, integration planning, and execution activities for acquisitions and business integrations.
  • Develop and lead the overall quality strategy and organizational Objectives and Key Results (OKRs), aligning enterprise, operating unit, and functional priorities.
  • Serve as the Quality Management System (QMS) leader, establishing and executing strategies to ensure FDA inspection readiness, including compliance with Quality Management System Regulation (QMSR) requirements.
  • Act as the front-room leader during FDA inspections and support other regulatory inspections at the Minneapolis site as needed.
  • Partner with and provide guidance to the PVH manufacturing facility on Quality Management System initiatives, regulatory compliance, and quality best practices.
  • Collaborate closely with the existing QMS support team responsible for Quality Management Review (QMR), Key Performance Indicators (KPIs), Corrective and Preventive Actions (CAPA), and other quality system processes.
  • Drive continuous improvement initiatives to strengthen quality systems, regulatory compliance, and operational effectiveness.
  • Build strong relationships with cross-functional stakeholders to ensure consistent implementation of quality standards and regulatory expectations.

Requirements

  • Baccalaureate with 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.
  • 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.

Skills

  • FDA experience: A demonstrated ability to interact with FDA during audits/questions.
  • Quality Management System Regulation (QMSR) experience is preferred.
  • Demonstrated ability to collaborate with manufacturing sites to reduce 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 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.

Benefits

Medtronic offers a competitive salary and flexible benefits package. The following benefits and additional compensation are available to 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)
  • 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)
  • 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.

Please note some of the above benefits may not apply to workers in Puerto Rico.

Pay

Salary ranges for U.S (excluding PR) locations (USD): $184,000.00 - $276,000.00. 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, and location.

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