SaMD Quality Engineer: Regulatory Docs & Audits

Proclinical; Western Australia; On-site; AUD 90,000 - 130,000; Full time

Job summary

Proclinical is seeking a Software Quality Engineer to contribute to the development and maintenance of technical documentation and ensure compliance with global regulatory and quality standards for SaMD products, including AI-enabled software. This role involves collaborating with cross-functional teams to support software lifecycle processes, risk management, and audit readiness.

The role requires familiarity with IEC 62304, ISO 13485, FDA CFR 820-QMSR, ISO 14971, and the ability to translate

Qualifications

• Experience authoring technical documentation for SaMD in regulated environments.
• Ability to translate complex engineering and AI/ML concepts into clear, structured documentation.
• Strong technical writing skills with attention to detail and version control.
• Proven ability to manage documentation across multiple stakeholders and meet tight deadlines.

Responsibilities

• Support and improve 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.
• Ensure documentation aligns with regulatory expectations and approved design changes.
• Establish and maintain end-to-end traceability across requirements, design, risk, implementation, testing, and release.
• Develop and track documentation plans and timelines aligned with product milestones.
• Support design and documentation reviews, ensuring outcomes are reflected in technical documentation.
• Facilitate audit and inspection readiness by organizing documentation and ensuring traceability.
• Support investigations related to software defects, customer complaints, CAPAs, and post-market feedback.
• Track and manage quality actions, ensuring timely updates to procedures and documentation.

Skills

Regulatory documentation

Technical writing

Software QA

Risk management

Traceability

Cross-functional coordination

Education

Bachelor's degree in engineering or software

Tools

Documentation tools (MS Word, Visio)

Job description

Proclinical is seeking a Software Quality Engineer to contribute to the development and maintenance of technical documentation and ensure compliance with global regulatory and quality standards for SaMD products, including AI-enabled software. This role involves collaborating with cross-functional teams to support software lifecycle processes, risk management, and audit readiness.

The role requires familiarity with IEC 62304, ISO 13485, FDA CFR 820-QMSR, ISO 14971, and the ability to translate