Sr. Director Software Quality (Medical Devices)

Location: San Diego, California, United States; full-time onsite role.

Salary: $205,100–$307,700 base salary annually, plus eligible bonus, commission, and equity opportunities.

Company

hirify.global develops genomic sequencing technology supporting early disease detection, diagnosis, treatment research, and health equity.

What you will do

• Establish and lead a standalone Software Quality organization, including its structure, operating model, headcount, and talent development.
• Define and own the global Software Quality Management System aligned with IEC 62304, ISO 14971, ISO 13485, QMSR, SaMD frameworks, and EU AI Act requirements.
• Embed software quality checkpoints, risk management, design reviews, and verification and validation standards into the product development lifecycle.
• Oversee software-specific post-market surveillance, cybersecurity vulnerability tracking, SOUP management, complaints, MDR/vigilance reporting, and CAPA.
• Represent Software Quality during FDA, BSI, MDSAP, KFDA, PMDA, and NMPA inspections and lead remediation of software-related observations.
• Partner with R&D, Regulatory Affairs, Commercial, Operations, and executive quality leadership across the global portfolio.

Requirements

• Deep hands-on expertise in IEC 62304 software lifecycle processes, including the ability to define, implement, and audit compliance.
• Experience with SaMD classification, IMDRF, FDA software guidance, EU MDR/IVDR, ISO 14971, ISO 13485, and software risk management.
• Working knowledge of EU AI Act requirements for medical device AI/ML software and cybersecurity standards including IEC 81001-5-1, TIR 57, TIR 97, and SOUP management.
• Proven experience building and leading software quality teams in a regulated medical device or IVD environment, including accountability at Senior Director level.
• 20+ years of experience in software quality, software engineering, or a related medical device or IVD function, with 10+ years of leadership experience.
• This role is not eligible for visa sponsorship. A bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.

Nice to have

• Advanced technical degree.
• Experience with both new product introduction and sustaining software quality for products already on the market.
• CSQE, CSSLP, or equivalent certification.

Culture & Benefits

• Inclusive, collaborative environment focused on genomics innovation and alternative perspectives.
• Health, dental, and vision coverage, retirement benefits, paid time off, and family planning support.
• Access to genomics sequencing and employee resource groups offering career development and cultural engagement opportunities.
• Equal pay commitment and equal employment opportunity regardless of legally protected characteristics.