VP of Quality Assurance, Software
San Francisco
Permanent
USD250000 - USD350000
Quality
PR/592099_1778534119
VP of Quality Assurance, Software
Vice President of Quality Assurance - Software
Location
San Francisco Bay Area, CA (Hybrid)
Role Overview
We are seeking a Vice President of Quality Assurance (Software) to lead and scale a global software quality organization. This executive will own the strategy, implementation, and continuous improvement of Quality Management Systems (QMS) and software quality practices to ensure compliance with FDA, ISO, and international regulatory standards.
Key Responsibilities
Leadership & Strategy
- Define and execute the global software quality strategy aligned with business objectives
- Build and lead a high-performing QA organization across multiple sites
- Partner with Engineering, Regulatory Affairs, Clinical, and Product teams
- Serve as a key member of the executive leadership team
Regulatory Compliance & Quality Systems
- Ensure compliance with:
- FDA 21 CFR Part 820 & Part 11
- ISO 13485
- IEC 62304 (medical device software lifecycle)
- ISO 14971 (risk management)
- Own and evolve the Software Quality Management System (QMS)
- Lead internal and external audits (FDA inspections, notified bodies)
- Ensure inspection readiness at all times
Software Quality & Validation
- Oversee software verification & validation (V&V) strategies
- Drive automation, continuous testing, and DevOps quality integration
- Ensure compliance of Software as a Medical Device (SaMD)
- Oversee cybersecurity and data integrity controls (FDA, ISO/IEC 27001 alignment)
Risk Management & Patient Safety
- Implement robust risk management processes for software
- Ensure traceability from requirements through validation
- Lead CAPA, deviation, and nonconformance processes
Cross-Functional Collaboration
- Work closely with R&D, Clinical, and Regulatory teams on product lifecycle
- Support regulatory submissions (510(k), PMA, CE Mark)
- Interface with external regulators and partners
Required Qualifications
Experience
- 12-15+ years in Quality Assurance within medical devices or SaMD
- 5+ years in executive leadership (VP or Director-level)
- Direct experience with Class III medical devices (PMA preferred)
- Deep experience in software quality and validation
Technical & Regulatory Expertise
- Strong knowledge of:
- IEC 62304
- FDA QSR / QMSR
- ISO 13485
- Experience leading FDA inspections and global audits
- Proven success implementing scalable QMS systems
Leadership Skills
- Experience scaling QA teams in high-growth environments
- Strong executive presence and stakeholder management
- Ability to influence across engineering and product organizations
Compensation & Benefits
- Base Salary: $250,000 - $350,000
- Bonus: Dependent on base salary
- Equity: Significant (varies by stage)
- Comprehensive health benefits, 401(k), and PTO
Preferred Qualifications
- Experience in AI/ML-based medical software
- Background in cybersecurity for medical devices
- Experience with global regulatory frameworks (EU MDR, MDSAP)
- Prior startup or scale-up experience
Why Join
- Work on life-saving Class III medical devices
- High-impact executive role with direct influence on patient safety
- Opportunity to build and modernize software quality in a growing organization
- Competitive compensation with strong equity upside