Join Albus Health as a Principal Software & Systems QA Test Engineer on a crucial contract. Focus on enhancing verification evidence for software-based medical devices in a remote work environment.
In this hands-on position, you will engage closely with Engineering and QARA teams to meticulously review and elevate verification strategies, acceptance criteria, and risk-control verification processes. Your expertise will directly influence FDA submission efforts, ensuring that technical evidence is robust and materially sufficient.
Key Responsibilities:
- Improve software and system requirements for clarity and traceability
- Critically assess verification plans and improve formal reports
- Enhance end-to-end traceability from requirements to outcomes
- Apply IEC and ISO standards to verification evidence
- Collaborate with engineers to remediate and refine documentation
Requirements:
- Significant experience in software/system verification for medical devices
- Strong knowledge of IEC 62304 and ISO 13485
- Background in verifying embedded software interactions
- Proven ability to document technical evidence effectively
- Experience supporting FDA submissions is preferred
Enhance regulatory readiness while shaping the quality assurance of innovative medical solutions at Albus Health.
Senior QA Engineer for Medical Devices in Oxford employer: Albus Health
Albus Health is an exceptional employer, offering a unique opportunity to work at the forefront of health data technology in a collaborative and innovative environment. With a strong focus on employee autonomy and growth, you will have the chance to take ownership of critical testing functions while enjoying flexible working arrangements in the vibrant city of Oxford. Our commitment to employee well-being is reflected in our generous benefits package, including share options, flexible hours, and regular team activities that foster a supportive work culture.
