Principal Software QA Engineer - Medical Devices (Remote)

Albus Health; Oxford; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

Albus Health in Oxford is seeking a Principal Software & Systems QA Test Engineer for a short-term contract to strengthen verification evidence for software-containing medical devices. You will review and improve requirements, verification approaches, acceptance criteria, and traceability, working with Engineering and QARA to support FDA submissions.

This hands-on role focuses on improving an existing verification programme rather than creating a new testing function, with emphasis on risk-based

Qualifications

• Substantial hands-on software and systems verification experience for regulated medical devices.
• Experience applying IEC 62304 to software-containing medical devices.
• Strong experience with ISO 13485 quality management systems.
• Familiarity with ISO 14971 risk-based verification and risk controls.

Responsibilities

• Review and improve system and software requirements, interfaces, and acceptance criteria for clarity and traceability.
• Critically assess verification plans, protocols, execution records, and formal verification reports; improve documentation where needed.
• Assess verification coverage across embedded software, hardware/software interfaces, and device-to-cloud functionality.
• Strengthen end-to-end traceability between requirements, hazards, risk controls, verification methods and results.
• Provide independent technical assessment of verification readiness and residual risks.

Skills

Software verification

Systems verification

Medical devices

IEC 62304

ISO 13485

ISO 14971

Traceability

Technical writing

Job description

Albus Health in Oxford is seeking a Principal Software & Systems QA Test Engineer for a short-term contract to strengthen verification evidence for software-containing medical devices. You will review and improve requirements, verification approaches, acceptance criteria, and traceability, working with Engineering and QARA to support FDA submissions.

This hands-on role focuses on improving an existing verification programme rather than creating a new testing function, with emphasis on risk-based