Sr. Director of Software Quality will build and lead Illumina's standalone Software Quality organization, establishing governance frameworks aligned with IEC 62304, ISO 13485, ISO 14971, and emerging AI Act requirements.… The role owns the Software Quality Management System across all software products, software-driven IVDs, and AI/ML-enabled diagnostics, embedding quality checkpoints throughout the product development lifecycle and post-market surveillance. Responsibilities include recruiting and developing a high-performing team, defining verification and validation standards, managing regulatory compliance for FDA, EU MDR/IVDR, and other global bodies, and serving as the subject-matter expert in regulatory inspections. The candidate must have deep hands-on expertise in IEC 62304, SaMD classification frameworks, cybersecurity in QMS (IEC 81001-5-1), and demonstrated experience building and leading software quality functions in regulated medical device environments.