Quality Assurance Engineer (Medical Device)

About the role

Enovis is seeking a Quality Assurance Engineer to lead and support QA activities across new product development and sustaining engineering programs for medical devices in Brisbane. The role ensures compliance with internal quality systems, industry standards and global regulatory requirements, driving continuous improvement throughout the product lifecycle.

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 and 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 supporting business functions.
• Evaluate non‑conforming material and support disposition decisions with engineering and manufacturing teams.
• Investigate product failures, complaints and trends to identify systemic issues.
• Lead and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution.

Required profile

• Strong technical judgment and deep knowledge of regulated environments for medical devices.
• Ability to influence cross‑functional teams and ensure product safety, quality and compliance.
• Experience with design controls, risk management and audit readiness.

Required skills

• DFMEA and UFMEA development.
• Risk management per ISO 14971.
• Design control documentation and verification/validation.
• Internal and external audit execution (ISO, FDA, GMP).
• CAPA management.
• Quality system procedures authoring and maintenance.