Job Description
Our client Volpara Health is on a mission to save families from cancer. As a global leader in medical imaging software and AI, Volpara isnow looking for aHead of Quality Affairs to lead theirquality management evolution and drive trust in everything theybuild.
This is more than a compliance role. It’s a rare opportunity to influence how a fast-growing health tech business navigates new frontiers like the EU AI Act, software-based medical devices, and global audits all while staying nimble and values-led.
You’ll be the architect and guardian of Volpara’s Quality Management System (QMS), acting as both a systems leader and cross-functional coach.
You will:
- Lead the maintenance and evolution of ISO 13485-certified QMS, ensuring it remains lean, effective, and globally compliant
- Own risk management across the lifecycle of medical device software under ISO 14971
- Guide the business through regulatory audits and readiness
- Implement new eQMSsoftware to enhance traceability, visibility, and efficiency
- Mentor the Quality Affairs team and upskill engineering and product partners
- ShapeVolpara’sresponse to the EU AI Act and future-proof how quality isembeddedinto next-gen healthcare technology
- Represent Volpara to external auditors, regulatory bodies, and global compliance stakeholders
What you’ll bring:
- 8–10+ years in Quality, Risk or Audit leadership roles (medical devices/software preferred)
- In-depth experience with ISO 13485 and ISO 14971 standards
- Familiarity with design control and quality in a software-as-medical-device environment
- Strong working knowledge of global medical regulations (US, EU, Japan, AU, Canada)
- Insight into AI/ML regulatory trends, privacy compliance, and information security
- A strategic mindset with proven influence across business leadership
- A people-first leadership style that promotes trust, accountability and excellence.
Ready to Apply? If you’re looking for a strategic leadership role where your impact is tangible and the mission is meaningful, we’d love to hear from you.
Apply now or reach out for a confidential chat.