Quality Assurance Engineer – Brisbane

About the role

Enovis is looking for a Quality Assurance Engineer to lead and support QA activities across new product development and sustaining engineering programmes in Brisbane, Australia. The role ensures compliance with internal quality systems, industry standards and global regulatory requirements while driving continuous improvement.

Key responsibilities

• Serve as the QA representative on new product development and sustaining engineering projects.
• Participate in design and manufacturing reviews to verify compliance with quality system requirements.
• Develop and maintain DFMEA/UFMEA documentation and lead risk‑management discussions aligned with ISO 14971.
• Review and approve design control documentation, including specifications, verification/validation records and design outputs.
• Act as subject‑matter expert for design quality during internal and external audits (ISO, FDA, GMP).
• Author, review and maintain quality system procedures, work instructions and controlled documentation.
• Conduct internal audits across quality system processes and support business functions.
• Evaluate non‑conforming material and collaborate on disposition decisions.
• Investigate trends in product failures, complaints and non‑conforming material to identify systemic issues.

Required profile

• Demonstrated experience as a QA engineer in regulated environments.
• Strong technical judgment and ability to influence cross‑functional teams.
• Knowledge of design controls, risk management and audit readiness.

Required skills

• DFMEA / UFMEA development.
• ISO 14971 risk‑management methodology.
• ISO, FDA and GMP audit processes.
• Design control documentation review.
• Internal audit execution.
• Non‑conforming material evaluation.