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.

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.

• 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.

• Bachelor's degree and 2+ years of relevant experience…