Quality Systems Specialist – Affera Software

Software Quality Systems Specialist

You will support quality system execution for Affera software products within the Cardiac Ablation Solutions Operating Unit. This role focuses on software‑related CAPAs, field corrective action execution & follow‑up, quality system compliance, process support, and metric tracking.

• 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 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.

Travel required: