Sr. Director Software Quality

Illumina Hub International Ltd

Base: $205,100 - $307,700; bonus/equity: variable ...
Not specified (assumed hybrid based on industry norms)
Iec 62304 software lifecycle expertise
Samd classification and risk management
Eu ai act implementation knowledge
Illumina is seeking a Sr. Director of Software Quality to lead its standalone Software Quality function, ensuring compliance with stringent regulatory standards in the medical device industry. The ideal candidate will possess deep technical expertise in software quality processes, leadership experience, and the ability to influence cross-functional teams

Job Summary

  • The Sr. Director will establish and lead Illumina's standalone Software Quality function to ensure compliance with demanding global regulations like the EU AI Act and IEC 62304.
  • This role requires deep technical expertise to own the end-to-end quality framework for all software products and software-driven medical devices across the global portfolio.
  • Candidates must have a proven track record of building quality systems from the ground up and representing software quality in FDA and international regulatory inspections.

Matching Summary

Match Score: 85

Illumina is seeking a Sr. Director of Software Quality to lead its standalone Software Quality function, ensuring compliance with stringent regulatory standards in the medical device industry. The ideal candidate will possess deep technical expertise in software quality processes, leadership experience, and the ability to influence cross-functional teams.

Salary

Base: $205,100 - $307,700; Bonus/Equity: Variable cash programs and equity eligible; Benefits: Health/dental/vision, retirement, paid time off

Skills & Requirements

Must-have

  • IEC 62304 software lifecycle expertise
  • SaMD classification and risk management
  • EU AI Act implementation knowledge
  • Cybersecurity in QMS (IEC 81001-5-1)
  • ISO 14971 and ISO 13485 standards
  • Build quality systems from ground up
  • FDA and international regulatory inspections

Nice-to-have

  • Experience with NPI and sustaining software
  • CSQE or CSSLP certifications
  • Strong executive presence
  • Cross-functional stakeholder influence
  • AI/ML diagnostic tool experience

Key Requirements

  • Bachelor's degree in Software Engineering or related field
  • 20+ years of experience in software quality or engineering
  • 10+ years of leadership experience managing software quality teams
  • Not eligible for visa sponsorship

Work Rights

Not specified

Tailored Resume

Cover Letter