Quality Systems Manager

COV Covidien LP; United States; 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

Tuition assistance

Incentive plans

Job summary

Medtronic plc in the United States is seeking a Quality Systems Manager for the Acute Care & Monitoring (ACM) organization. You will lead a team of Quality Engineers and Quality Systems Specialists, overseeing CAPA, audit readiness, training administration, management reviews, and change management to ensure compliant, effective quality systems across global sites.

You will collaborate with Regulatory, Operations, R&D, and Enterprise Quality to implement procedures, monitor KPIs, and drive

Qualifications

• CAPA experience required.
• Strong audit management experience.
• Working knowledge of medical device regulations and Quality Systems requirements.

Responsibilities

• Provide leadership for development and maintenance of Quality System programs.
• Lead and develop Quality Engineers and Specialists across CAPA, audits, training, and procedures.
• Oversee audit/inspection readiness and closure of findings.

Skills

CAPA experience

Audit management

Regulatory knowledge

Education

Bachelor's degree

Master's degree

Job description

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.

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 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 pertain solely to candidates hired within the United States (local market compensation and benefits will apply for others).

• 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)
• 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.

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.

For sales reps and other patient‑facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail] To request removal of your personal information from our systems please email [e-mail].