Quality Systems Specialist – Affera Software
Core
Ensure software-related quality system compliance, execute CAPAs and field corrective actions, and maintain audit-ready records for Affera cardiac ablation software.
Role type
Quality Systems Specialist (Medical Device Software)
Builds
Software quality system records, CAPA documentation, and field action evidence for Affera products.
Domain
Medical device software / Cardiac ablation solutions
Deliverable
dashboards & analysis
Required skills
CAPA management, field corrective action execution, audit readiness, regulatory interpretation, metric tracking, documentation control
Preferred skills
FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 62366, 21 CFR Part 11, EU MDR, software cybersecurity, TrackWise, Agile PLM, Jira
Responsibilities
Lead audit and inspection readiness for software quality areas; support execution of software-related CAPAs and field corrective actions; maintain and track quality metrics; partner with cross-functional teams to resolve quality system issues; assist with closure of audit findings; identify opportunities to improve quality system processes.
Seniority
Mid-level, hands-on IC