Senior Quality Systems Specialist

We anticipate the application window for this opening will close on - 23 Mar 2026

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Onsite

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.

In this dynamic role as a Senior Quality System Specialist, you will play a key role in overseeing the development, implementation, and maintenance of quality systems, programs, processes, and procedures that ensure compliance with company policies and regulatory standards. You will work both independently and collaboratively across teams and functions to uphold the highest standards of quality and performance.

Job Responsibilities

Responsibilities include the following and other duties may be assigned:

• Lead the Corrective and Preventive Actions (CAPA) Program, including root cause investigations, application of analysis tools, action planning, execution, and verification of effectiveness.
• Prepare and deliver communications, reports, and documentation related to CAPA activities to internal and external stakeholders.
• Drive audit and inspection readiness—manage all phases of audits, resolve findings, and serve as liaison with auditors, inspectors, and internal stakeholders.
• Apply a continuous improvement mindset to enhance quality tools, processes, and overall system effectiveness.
• Provide expert interpretation of policies, regulations, and standards to ensure full compliance across the organization.
• Coordinate responses to legal or regulatory requests, including those supporting investigations or litigation.
• Maintain and update quality assurance programs and policies to reflect evolving standards and best practices.
• Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Quality, and Program Management Office to effectively maintain the Quality Management System.
• Generates and analyzes standard reports (e.g., Periodic Review, External Standards, Training, and Quality Data Analysis) for compliance with KPIs, identification of patterns of underperformance to KPIs
• Coordinates with Quality System Program Manager on the generation of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP

Must Have (Minimum Requirements)

• Bachelor degree with minimum of 4 years quality assurance experience in medical device or pharmaceutical industry.

Nice to Have (Preferred Qualifications)

• Demonstrated continuous improvement mindset with hands-on experience using quality tools and process improvement methodologies.
• Strong working knowledge of Quality Management Systems (QMS) compliant with ISO 13485 standards, FDA regulatory, EU MDR, and MDSAP requirements.
• Proven experience managing Corrective and Preventive Actions (CAPA), audits, and Change Control Processes.
• Functional experience in root cause investigation, including application of root cause analysis tools, corrective/preventive action planning, execution, and verification of effectiveness.
• Proficiency with TrackWise and Agile PLM systems.
• Familiarity with change management frameworks and document control processes.
• Excellent communication (verbal and written), critical thinking, interpersonal, organizational, time management, and presentation skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and collaboratively within teams and across functions.

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.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

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):$89,600.00 - $134,400.00

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).

 

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).

 

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

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here.

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.