Sr. Director Software Quality
Core
Establish and lead Illumina's standalone Software Quality function to ensure compliance with IEC 62304, SaMD classification, EU AI Act, and cybersecurity for global software products and medical devices.
Role type
Sr Director, Software Quality (Regulated Medical Device)
Builds
Global Software Quality Management System (SQMS) and compliant software quality teams for IVD and AI/ML-enabled diagnostic tools
Domain
Medical Device / In Vitro Diagnostics (IVD) / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis
Required skills
IEC 62304 lifecycle expertise, SaMD classification (IMDRF/FDA), EU AI Act compliance, ISO 14971 risk management, ISO 13485 QMS, IEC 81001-5-1 cybersecurity, software V&V, DFMEA, post-market surveillance (PMS), regulatory inspection readiness
Preferred skills
NPI and on-market sustaining quality experience, CSQE or CSSLP certification
Technologies
IEC 62304, ISO 14971, ISO 13485, IEC 81001-5-1, TIR 57, TIR 97, SOUP management
Responsibilities
Define and own the global Software Quality Management System (SQMS); Recruit and lead a high-performing software quality engineering team; Serve as primary quality authority for software products and AI/ML tools; Partner with R&D to integrate quality checkpoints into the Product Development Process; Lead post-market surveillance and CAPA processes for software; Represent software quality in international regulatory inspections
Seniority
Sr Director, executive leadership with cross-functional influence