Sr. Director Software Quality

Role: Sr. Director of Software Quality at Illumina, responsible for establishing and leading the standalone Software Quality function for all software products and medical devices, including AI/ML-enabled tools. Responsibilities: build the organizational structure, recruit and develop a high-performing team, define and own the global Software Quality Management System (SQMS) aligned with IEC 62304, ISO 14971, ISO 13485, and regulatory frameworks such as EU AI Act; embed quality checkpoints into product development, oversee post-market surveillance, CAPA, and complaint investigations; serve as subject matter expert for regulatory inspections and represent software quality in executive forums; stay current with evolving regulations and translate into proactive quality strategies. Requirements: 20+ years in software quality or engineering within regulated medical device or IVD industry; 10+ years of leadership experience managing software quality teams; deep expertise in IEC 62304, SaMD classification, risk management (IMDRF, FDA, EU MDR/IVDR), cybersecurity, and ISO standards; bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or related field; certifications like CSQE or CSSLP preferred. High-value specifics: focus on software-driven diagnostics, AI/ML applications, compliance with IEC 62304, EU AI Act, cybersecurity standards, and international regulatory inspection experience. Work setup: role based in the U.S., with responsibilities that include influencing global regulatory compliance and quality initiatives.