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 setting. 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