Quality Systems Specialist – Affera Software

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. #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. 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 ta