Quality Systems Specialist – Affera Software

Medtronic; Mounds View (MN); On-site; USD 75,000 - 113,000; Full time

Job summary

Medtronic is seeking a Software Quality Systems Specialist to support software quality system execution for Affera software products within the Cardiac Ablation Solutions unit. This onsite role focuses on CAPAs, field actions, and compliance activities across cross-functional teams to ensure audit readiness and robust documentation.

The candidate will work with Quality, R&D, Regulatory, Medical Safety, and Product Security teams to maintain complete, audit-ready records and drive continuous

Qualifications

• Bachelor's degree with 2+ years in quality systems.
• Experience coordinating multiple deliverables and action items.
• Strong written and verbal communication for controlled documents.
• Ability to interpret procedures and apply quality system requirements.

Responsibilities

• Leads audit and inspection readiness for software quality system areas, including CAPA records and metrics.
• Guides interpretation of policies, regulations, and internal procedures to ensure compliance.
• Supports assessment of regulatory changes for software areas.
• Executes software CAPAs with organized owners and tracking.
• Coordinates field corrective actions for Affera software and tracks status.
• Collaborates with Quality, R&D, Regulatory, Medical Safety, Product Security and Field Quality teams.
• Maintains and tracks KPIs for software quality activities and prepares weekly reports.
• Provides process oversight with cross-functional teams to ensure compliant delivery.
• Assists with closure of audit findings and corrective actions.
• Supports integration and stabilization of software quality systems for larger deployments.
• Identifies opportunities to improve quality system execution and documentation.

Skills

Quality system knowledge

CAPA management

Regulatory compliance

Cross-functional collaboration

Documentation control

Education

Bachelor's degree

Advanced degree

Tools

TrackWise

Jira

Agile PLM

Job description

We anticipate the application window for this opening will close on - 28 Sep 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

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.

This position is based onsite and follows Medtronic’s minimum four-day-per-week onsite work model. Travel requirement is less than 20%.

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 and inspection readiness for software quality system areas, including CAPA records, field action records, metrics, procedures, and related objective evidence.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance.
• Supports Changing Regulation Notification assessments 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 support timely and 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.
• Assist with 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.
• Identify opportunities to improve quality system execution, documentation quality, metric visibility, and process effectiveness for software quality activities.

Required Qualifications

• Bachelor's degree and 2+ years of relevant experience OR an advanced degree with 0+ years of relevant experience.
• Experience coordinating multiple deliverables, tracking action items, and supporting timely completion of quality system activities.
• Strong written and verbal communication skills with experience preparing or reviewing controlled documentation.
• Ability to interpret procedures and apply quality system requirements to day-to-day execution activities.

Preferred Qualifications

• Experience in the medical device, pharmaceutical, biotechnology, or other quality system-regulated industry.
• Knowledge of quality and software regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 62366, 21 CFR Part 11, European Union Medical Device Regulation (EU MDR), and software cybersecurity guidance.
• Experience supporting quality systems, compliance, regulated products, software quality, or related quality assurance activities
• Experience supporting quality system documentation, records management, compliance activities, or process execution within a regulated environment.
• Experience supporting CAPA programs, root cause investigations, corrective action implementation, and verification of effectiveness activities.
• Experience supporting audit readiness, audit responses, inspection preparation, or closure of audit findings.
• Experience using quality system and product lifecycle tools such as TrackWise, Agile Product Lifecycle Management (PLM), Jira, or similar systems, and developing quality metrics, dashboards, or key performance indicator (KPI) reporting.

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):$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.

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.

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 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.