OrganOx · 11–50 people · Series B
Software Quality Engineer
- Oxford
- On-site
- Mid-level
- Permanent
Assures software quality across the full lifecycle for medical devices up to IEC 62304 safety class C, covering design controls, requirements, verification and validation, and release management. A central duty is software risk management, developing and maintaining SFMEAs, hazard analyses and cybersecurity risk assessments aligned with ISO 14971. Works with R&D, Engineering, Post-Market Operations, Regulatory Affairs and Cybersecurity to support EU MDR and FDA compliance.
IEC 62304 · ISO 14971 · ISO 13485 +5