Quality Systems Specialist - Affera Software

In this role as a Software Quality Systems Specialist, you will support quality system execution for Affera software products within the Cardiac Ablation Solutions Operating Unit. This role will focus on software-related CAPAs, field corrective action execution and follow-up, quality system compliance, process support, and metric tracking.

You will work closely with Quality, R&D, Regulatory, Medical Safety, Service, Enterprise teams, and other cross-functional partners to ensure software-related quality system records are complete, timely, audit-ready, and aligned with internal procedures and external regulatory expectations. This position is intended for a quality systems professional with strong compliance discipline, good technical judgment, and the ability to manage multiple quality system deliverables in a complex medical device software environment.

Primary Responsibilities

• Leads on-going audit andinspectionreadiness for software quality system areas, including CAPA records, field action records, metrics, procedures, and related objective evidence.
• Providesexpertiseand guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance.
• Supports Changing RegulationNotificationassessments for software-related areas.
• Support execution of software-related CAPAs, including organization and education of CAPA owners, action tracking, documentation review, implementation support, and support for verification of effectiveness activities.
• Support field corrective action execution for Affera software, including coordination of action items, follow-up activities, evidence collection, and status tracking.
• Partner with Software Quality, R&D, Regulatory, Medical Safety, Product Security, Customer Quality, and Field Quality teams to supporttimelyand compliant resolution of software-related quality systems and procedural issues.
• Maintain and track metrics related to software and security CAPAs, field actions, quality system deliverables, action item closure, and other software quality indicators, preparing weekly reports and management review inputs.
• Support review of and changes to quality system records for completeness, consistency, traceability, and compliance with internal procedures and regulatory expectations.
• Work directly with cross-functional teams to provide process oversight, reinforce quality system requirements, and support compliant execution of assigned deliverables.
• Assistwith closure of audit findings, corrections, corrective actions, and preventive actions related to software quality system processes.
• Support software-related quality system integration and stabilization activities as processes, tools, and procedures scale to support larger field usage and continue to align with Medtronic requirements.
• Identifyopportunities to improve quality system execution, documentation quality, metric visibility, and process effectiveness for software quality activities.

• Bachelor's degree anda minimum of2years of relevant experience
• ORadvanceddegree witha minimum of0years of relevant experience

Preferred Qualifications

• Experience working in a regulated environment, preferably medical devices, pharmaceutical, biotechnology, or another quality system-controlled industry.
• Experience supporting quality system records, documentation, process execution, or compliance activities.
• Strong written and verbal communication skills, including the ability to document quality system rationale clearly and accurately.
• Strong organizational skills with the ability to track multiple deliverables, follow up on action items, and supporttimelyclosure of quality system activities
• Working knowledge of medical device quality system requirements and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, IEC 62366, 21 CFR Part 11, EU MDR, AAMI TIR57, FDA Software and Cybersecurity Guidance documents, and/or internal quality system requirements.
• Experience supporting CAPA activities, including root cause investigation, corrective and preventive action planning, execution tracking, and verification of effectiveness.
• Experience supporting field corrective actions or other post-market quality system activities.
• Experience working with software products, software quality, softwaredevelopmentlifecycle processes, or software-related investigations.
• Experience with quality system documentation tools, CAPA systems, issue management systems, or product lifecycle documentation systems such asTrackWise, Agile PLM, JIRA, or similar tools.
• Experience supporting audit preparation, audit observation responses,inspectionreadiness, or closure of audit findings.
• Ability to interpret procedures and regulatory requirements and apply them to practical quality system execution.
• Experience developing or supporting quality metrics, dashboards, management review inputs, or KPI tracking.
• Strong analytical and decision-making skills.
• Strong interpersonal skills with the ability to work constructively across Quality, R&D, Regulatory, Medical Safety, Field, Enterprise, and business teams.
• Experience with process improvement methods, quality tools, or structured problem-solving techniques.
• Familiarity with cardiac electrophysiology products, capital equipment, or complex medical device software.

#LI-MDT

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.

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):$75,200.00 - $112,800.00

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.

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 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., If you are applying to perform work for Medtronic, Inc. 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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, 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 our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. 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