Software Quality Engineer: Medical Devices (Oxford, Onsite)

OrganOx in Oxford, UK, is seeking a Software Quality Engineer to drive quality across the software lifecycle for medical device applications, including SaMD and cybersecurity considerations. You will partner with R&D, Engineering, and Regulatory Affairs to ensure robust risk management and regulatory compliance.

The role focuses on SFMEAs, software hazard analyses, traceability, and documentation aligned with ISO 13485, IEC 62304, EU MDR, and FDA requirements.

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