VP of Quality Assurance, Software
Vice President of Quality Assurance - Software
Location
Role Overview
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
FAQs
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