Quality Systems Manager

Medtronic plc; Lafayette (CO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, dental, vision

401(k) with match

Paid time off

Tuition assistance

Job summary

Medtronic plc in Lafayette, Colorado is seeking a Quality Systems Manager to lead the ACM quality initiatives and teams. The role focuses on CAPA, audits, training, and regulatory compliance across the portfolio and sites.

You will partner with Regulatory, Operations, R&D, and Enterprise Quality Systems to ensure effective, compliant processes and continuous improvement. A strong background in medical device quality systems is required.

Qualifications

• Bachelor's degree with 5 years of relevant experience OR Master's degree with 3 years of relevant experience.
• Direct CAPA experience.
• Strong audit management experience, ideally having directly run audits.
• Working knowledge of applicable medical device regulations, standards, and Quality Systems requirements.

Responsibilities

• Provides leadership for the development, implementation, and maintenance of Quality System programs to ensure regulatory compliance across the ACM portfolio.
• Leads a team of Quality Engineers and Quality Systems Specialists supporting Quality System activities.
• Oversees CAPA program, ensuring investigations are thorough and timely with appropriate corrective actions.
• Interprets Quality System policies and regulatory requirements to support ongoing compliance.
• Leads audit and inspection readiness, coordination with SMEs, and communication with inspectors.
• Oversees timely closure of audit findings and follow-up actions across sites.
• Partners with cross-functional stakeholders to improve Quality System processes and performance.
• Leads periodic management reviews and presents metrics to leadership.

Skills

CAPA management

Audit management

Regulatory knowledge

Quality systems leadership

Education

Bachelor's degree +5 years

Master's degree +3 years

Job description

Onsite

Lafayette, Colorado, United States of America

Full time

R81164

We anticipate the application window for this opening will close on - 18 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

Medtronic’s Acute Care & Monitoring (ACM) business develops technologies that help clinicians monitor patients, identify changes in their condition, and make informed decisions across the continuum of care. The portfolio includes patient monitoring and respiratory-focused solutions designed to support care teams in acute and procedural settings, helping improve clinical insights and patient outcomes.

The Quality Systems Manager will provide leadership and oversight for Quality Systems activities supporting the ACM organization across its product portfolio and global sites. This role will lead a team of Quality Engineers and Quality Systems Specialists responsible for key Quality Management System activities, including CAPA management, audit and inspection management, training administration, management reviews, procedure implementation, and ongoing Quality System compliance.

In addition to leading and developing the team, this individual will serve as a key Quality Systems partner to cross-functional stakeholders across Regulatory, Operations, R&D, Change Management, and Enterprise Quality Systems. The role will provide both strategic oversight and hands‑on support to ensure Quality System processes are effective, compliant, and continuously improving.

Primary Responsibilities

• Provides leadership and oversight for the development, implementation, and maintenance of Quality System programs, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and applicable standards.

• Leads and develops a team of Quality Engineers and Quality Systems Specialists responsible for supporting Quality System activities across the operating unit.

• Provides oversight of the CAPA program, partnering with CAPA owners to ensure investigations are thorough, corrective and preventive actions are appropriate, and CAPAs progress effectively and within established timelines.

• Provides expertise and guidance in interpreting Quality System policies, regulatory requirements, standards, and internal procedures to support ongoing compliance across the organization.

• Leads audit and inspection readiness, preparation, and execution, including coordination of audit activities, engagement with internal subject matter experts, and communication with auditing groups and inspectors.

• Oversees the resolution and timely closure of audit and inspection findings, including ensuring appropriate ownership, response plans, corrective actions, and follow‑up activities are established and completed.

• Partners directly with operating entities and cross‑functional stakeholders to assess Quality System processes, identify areas for improvement, and ensure requirements are consistently implemented.

• Leads and supports periodic management reviews by coordinating stakeholder inputs, reviewing Quality System performance and metrics, developing management review content, and presenting information to organizational leadership.

• Oversees implementation of new or revised enterprise Quality System procedures and requirements, ensuring the operating unit evaluates changes and effectively incorporates applicable requirements into its processes.

• Provides oversight for Quality System training administration, procedure implementation, periodic reviews, and other activities necessary to maintain an effective and compliant Quality Management System.

• Monitors Quality System performance, trends, KPIs, and compliance activities to identify risks, improvement opportunities, and areas requiring additional support or training.

• Leads or supports Quality System improvement initiatives and special projects.

• Promotes consistent Quality System standards and best‑practice sharing across the organization while fostering a culture of quality, accountability, collaboration, and continuous improvement.

Required Qualifications

• Bachelors degree with 5 years of relevant experience OR Masters degree with 3 years of relevant experience

• Direct CAPA experience

• Strong audit management experience, ideally having directly run audits.

• Working knowledge of applicable medical device regulations, standards, and Quality Systems requirements.

Preferred Qualifications

• FDA inspection or Notified Body auditing experience

• Medical device or pharmaceutical industry experience.

• People leadership experience

• Promote an inclusive, accountable, responsive, and continuous‑ improvement culture

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, and Simple Steps (global well‑being program).

• 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

• 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united‑states/employee-support-services/careers/la‑county‑legal‑notice.pdf) 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.

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