Sr. Director Software Quality

Illumina • San Diego, CA

1d

About The Position

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.

Requirements

• 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 integration
• 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 leadership
• Experience representing software quality in FDA, BSI, MDSAP, or equivalent international regulatory inspections
• Comfortable owning software-related observations and CAPA responses, including interaction with regulatory bodies
• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical discipline required; advanced degree preferred
• 20+ years of experience in software quality, software engineering, or a closely related function in the medical device or IVD industry
• 10+ years of leadership experience managing software quality teams or programs
• Experience in both NPI (new product introduction) and on-market sustaining software quality preferred
• Certifications desirable: CSQE (Certified Software Quality Engineer), CSSLP (Certified Secure Software Lifecycle Professional), or equivalent

Responsibilities

• Build and lead the Software Quality function
• Own the regulatory and compliance framework for software
• Embed software quality into the product development lifecycle
• Lead post-market software quality oversight
• Operate as a senior quality leader

Benefits

• access to genomics sequencing
• family planning
• health/dental/vision
• retirement benefits
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 1,001-5,000 employees