Sr. Director Software Quality

What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Position Summary: As sequencing technology advances into clinical, diagnostic, and AI-driven applications, the regulatory and quality requirements governing software have become as demanding as those governing physical devices. IEC 62304 compliance, SaMD classification, EU AI Act readiness, and cybersecurity within the QMS are front-line regulatory risks.The Sr Director, Software Quality will establish and lead Illumina's standalone Software Quality function, reporting directly to the VP of Global Quality. This leader will define the operating model, build the team, and own the end-to-end quality framework for all software products and software-driven medical devices across Illumina's global portfolio. The role requires deep technical expertise, executive presence, and the ability to work cross-functionally with R&D, Regulatory Affairs, and Commercial to ensure software quality is embedded from design through post-market surveillance.Responsibilities: Build and lead the Software Quality function ▪ Establish Illumina's standalone Software Quality organization - defining structure, headcount, roles, and operating model▪ Recruit, develop, and retain a high-performing team of software quality engineers with depth in IEC 62304, SaMD risk management, and cybersecurity▪ Serve as the primary quality authority for all software products, software-driven IVDs, and AI/ML-enabled diagnostic tools across the global portfolioOwn the regulatory and compliance framework for software ▪ Define and own Illumina's global Software Quality Management System (SQMS) in alignment with IEC 62304, ISO 14971, ISO 13485, and QMSR (21 CFR Part 820)▪ Lead the implementation and ongoing compliance of the EU AI Act quality and risk management requirements for AI/ML-enabled products▪ Ensure all software products are correctly classified under SaMD frameworks (IMDRF, FDA Software Guidance) and that quality requirements are appropriately applied▪ Drive IEC 81001-5-1 and cybersecurity-in-the-QMS implementation and maintenance activitiesEmbed software quality into the product development lifecycle▪ Partner with R&D to integrate software quality checkpoints into the Product Development Process (PDP): stage gates, design reviews, and risk assessments ▪ Own software-specific DFMEA, hazard analysis, and software risk management file requirements across IVD and RUO product lines▪ Define and enforce software verification and validation (V&V) standards across all development teams▪ Collaborate with Design Quality to maintain clear delineation between hardware and software quality responsibilities within the PDPLead post-market software quality oversight ▪ Establish software-specific post-market surveillance (PMS) processes, including software update monitoring, cybersecurity vulnerability tracking, and SOUP (Software of Unknown Provenance) management▪ Own the software CAPA process in collaboration with the Global Quality Ops team, ensuring software-origin findings are root-caused and resolved with appropriate rigor▪ Manage software-related complaint investigations and MDR/vigilance reporting obligations in partnership with the Complaints and PMS functionOperate as a senior quality leader ▪ Serve as the subject matter expert for software quality in regulatory inspections (FDA, BSI, MDSAP, KFDA, PMDA, NMPA) and respond to observations requiring software quality remediation▪ Represent Software Quality on the monthly Quality Council and contribute to the quarterly Executive Quality Council▪ Build strong working relationships with VP-level leaders across R&D, Regulatory Affairs, Commercial, and Operations▪ Stay ahead of the regulatory landscape: EU AI Act implementation timelines, IMDRF SaMD updates, FDA cybersecurity guidance, and translate changes into proactive QMS updatesRequirements:Technical expertise▪ IEC 62304: Deep, hands-on expertise in software lifecycle processes, not just awareness, but the ability to define, implement, and audit compliance▪ SaMD classification and risk management: Demonstrated experience with IMDRF, FDA, and EU MDR/IVDR frameworks▪ EU AI Act Working knowledge of requirements as they apply to medical device AI/ML software, including risk classification, technical documentation, and transparency obligations. Proficiency in cybersecurity within the QMS context: IEC 81001-5-1, TIR 57, TIR 97, and SOUP management▪ ISO 14971 Strong foundation in risk management as applied to software, and ISO 13485 quality system requirements. Familiarity with software V&V methodologies, unit testing frameworks, software configuration management, and CI/CD quality integrationLeadership and organizational experience ▪ Proven track record building and leading software quality teams in a regulated medical device or IVD environment▪ Experience operating at the Sr Director level with direct accountability to senior quality or regulatory leadership▪ Demonstrated ability to influence cross-functional stakeholders, including: engineering, product management, and regulatory, without direct authority▪ Track record of building quality systems from the ground up, not just inheriting and maintaining existing ones▪ Strong executive presence with the ability to communicate complex software risk clearly to non-technical leadershipInspection and audit readiness ▪ Experience