Quality Systems Program Manager

Medtronic plc; Mounds View (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

Medtronic plc in Minnesota is seeking a Quality Systems Program Manager to strengthen CAPA processes and drive continuous improvement across the CAPA lifecycle. This role emphasizes cross-functional collaboration, structured problem solving, and adherence to strict regulatory standards in a fast-paced, highly regulated environment.

You will partner with functions across the business to ensure timely, effective and compliant execution of quality system requirements, contributing to patients'

Qualifications

• Bachelor's degree required.
• 5 or more years of quality systems experience; or 3+ years with an advanced degree.

Responsibilities

• Manage and support Corrective and Preventive Action (CAPA) processes from investigation through root cause analysis, action planning, implementation and effectiveness verification.
• Lead quality system initiatives to improve compliance, consistency and efficiency in CAPA; identify risks, recurring issues and opportunities.
• Facilitate structured problem-solving using root cause analysis, risk assessment and continuous improvement tools.
• Contribute to documentation, training and governance related to quality systems and CAPA.
• Communicate with stakeholders at all levels for timely escalation and alignment on issues.
• Support change management related to quality systems processes and improvements.

Education

Bachelor's Degree

Tools

Lean Six Sigma Green Belt

Job description

We anticipate the application window for this opening will close on - 5 Nov 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 Electro Physiology Technologies (EPT) business unit is focused on advancing innovative solutions that support the diagnosis and treatment of cardiac rhythm disorders. The team works collaboratively to develop, deliver, and improve technologies that help clinicians provide effective patient care. Operating in a fast-paced, highly regulated environment, the business unit emphasizes quality, innovation, cross‑functional partnership, and continuous improvement to support both customer needs and long‑term business success.

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 a minimum of 4 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.

This position will be based in Mounds View, MN.

At Medtronic, we believe quality is foundational to delivering innovative therapies that help people live healthier lives. We are seeking a Quality Systems Program Manager to join the new Electrophysiology Therapies (EPT) CAPA team and help strengthen quality system performance through structured problem solving, cross‑functional collaboration, and continuous improvement. In this role, you will serve as a key contributor to quality system processes with a strong focus on CAPA leadership, systemic issue resolution, and operational excellence. You will partner closely with functions across the business to drive timely, effective and compliant execution of quality system requirements. This is an opportunity to make a meaningful impact by helping ensure the quality and integrity of products that support patient care around the world. You will join a team committed to excellence, innovation, and continuous improvement.

Role and Responsibilities

• Manage and support the Corrective and Preventive Action process, including investigation, root cause analysis, action planning, implementation, and effectiveness verification; partnering with cross‑functional teams to address quality issues and drive sustainable solutions.
• Lead or support quality system initiatives that improve compliance, consistency, and efficiency in the CAPA space by identifying risks, recurring issues, and improvement opportunities.
• Facilitate problem‑solving efforts using structured methodologies such as root cause analysis, risk assessment, and continuous improvement tools.
• Contribute to documentation, training and governance activities related to quality systems and CAPA.
• Communicate clearly with stakeholders at all levels, ensuring timely escalation and alignment on key issues.
• Support change management efforts related to quality systems processes and process improvements.

Must Have; Minimum Requirements

• Bachelors Degree
• Minimum of 5 years of quality systems experience, or advanced degree with a minimum of 3 years of quality systems 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.

Nice to Have: Preferred Qualifications

• Lean Six Sigma Green Belt certification preferred.
• Experience in medical device, healthcare, pharmaceutical, or other regulated industries.
• Proven ability to lead cross‑functional projects and influence without direct authority.
• Strong analytical, communication, and organizational skills.
• Experience using quality metrics, dashboards, or trend analysis to drive action.
• Strong facilitation skills and comfort leading meetings with multiple stakeholders at multiple leadership levels.
• A strong sense of accountability, follow‑through, curiosity and persistence.

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 esse