SaMD Software Quality Engineer - Regulated AI & Compliance

Proclinical; Western Australia; On-site; AUD 90,000 - 120,000; Full time

Job summary

Proclinical seeks a Software Quality Engineer to drive SaMD documentation and compliance across the software lifecycle in a regulated môi environment. You will author, update, and maintain design inputs/outputs, traceability, and risk controls, aligning with IEC 62304 and ISO 13485.

The role emphasizes collaboration with cross-functional teams to ensure audit readiness and robust documentation for AI-enabled software in a global context.

Qualifications

• Experience authoring technical documentation for SaMD in regulated environments.
• Familiarity with IEC 62304, ISO 13485, FDA 21 CFR Part 820-QMSR, and ISO 14971.
• Ability to translate complex engineering and AI/ML concepts into clear, structured documentation.

Responsibilities

• Support and maintain software lifecycle processes in compliance with IEC 62304, ISO 13485, and other regulatory requirements.
• Participate in design reviews, verification/validation activities, risk assessments, and release readiness reviews.
• Assist in software risk management, including hazard analysis and traceability of risk controls.
• Maintain software configuration and change management records for compliance and audit readiness.
• Contribute to cybersecurity and SOUP documentation activities.
• Author, update, and maintain technical documentation, including design inputs/outputs and traceability matrices.

Skills

Regulatory compliance

Technical writing

Software lifecycle

AI/ML understanding

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Document management software

Version control systems

Job description

Proclinical seeks a Software Quality Engineer to drive SaMD documentation and compliance across the software lifecycle in a regulated môi environment. You will author, update, and maintain design inputs/outputs, traceability, and risk controls, aligning with IEC 62304 and ISO 13485.

The role emphasizes collaboration with cross-functional teams to ensure audit readiness and robust documentation for AI-enabled software in a global context.