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 work from home 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 (Oxford County)
🏢 Albus Health
📍 Oxford County