Illumina

Sr. Director Software Quality

US - California - San Diego · Director

H1B sponsorship available$205k-$308kDetected 27 days ago

CI/CDMachine LearningCybersecurityComplianceFDA RegulatoryMedical DevicesLeadershipCollaborationRegulatory Affairs

About the role

IEC 62304 compliance, SaMD classification, EU AI Act readiness, and cybersecurity within the QMS are front-line regulatory risks.

Build and lead the Software Quality function
Recruit, develop, and retain a high-performing team of software quality engineers with depth in IEC 62304, SaMD risk management, and cybersecurity
Own 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
Drive IEC 81001-5-1 and cybersecurity-in-the-QMS implementation and maintenance activities
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
Collaborate with Design Quality to maintain clear delineation between hardware and software quality responsibilities within the PDP
Lead post-market software quality oversight
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

Technical expertise
SaMD classification and risk management: Demonstrated experience with IMDRF, FDA, and EU MDR/IVDR frameworks
Proficiency in cybersecurity within the QMS context: IEC 81001-5-1, TIR 57, TIR 97, and SOUP management
Familiarity with software V&V methodologies, unit testing frameworks, software configuration management, and CI/CD quality integration
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
Strong executive presence with the ability to communicate complex software risk clearly to non-technical leadership

Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical discipline required
advanced degree preferred
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

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.
Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package.
We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
Placement depends on experience, skills, location, and internal equity.

Working at Illumina means being part of something bigger than yourself.
Every person, in every role, has the opportunity to make a difference.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission.
We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race.

If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com.

This listing is sourced directly from Illumina's careers page and normalized into a canonical job model.