Quality Systems Specialist – Affera Software

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.

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.

• Lead ongoing audit and inspection readiness for software quality system areas, including CAPA records, field action records, metrics, procedures, and related objective evidence.
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance.
• Support changing regulation notification assessments for software‑related areas.
• Execute software‑related CAPAs, including organization and education of CAPA owners, action tracking, documentation review, implementation support, and 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 a minimum of 2 years of relevant experience.
• OR advanced degree with a minimum of 0 years of relevant experience.

• 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 support timely closure of quality system activities.
• Working knowledge of medical device quality system requirements and standards, including FDA 21 CFR 820, ISO…