QA Engineer – Medical Devices & SaMD

About the role

Join a global medical technology organisation as a QA Engineer, supporting quality and compliance across medical devices and software as a medical device (SaMD). You will work within a collaborative, quality‑focused environment, partnering with Regulatory Affairs, Engineering, Operations, Sales and Marketing.

Key responsibilities

• Support compliance with ISO 13485, ISO 14971 and internal QMS requirements.
• Assist with internal, external and TGA audits and inspections.
• Investigate and document complaints, non‑conformances and CAPAs.
• Conduct risk assessments and drive continuous quality improvement.
• Maintain controlled documents and quality records within the QMS.
• Provide quality and compliance training across the organisation.
• Support design controls activities for new product development.
• Participate in cross‑functional projects to ensure regulatory requirements are met.

Required profile

• Bachelor’s degree in Engineering, Science or related discipline.
• Minimum 2 years experience in Quality Assurance within the medical device industry.
• Strong analytical and problem‑solving abilities.
• Collaborative approach with ability to work across multiple business functions.

Required skills

• Working knowledge of ISO 13485.
• Working knowledge of ISO 14971.
• Experience with SaMD (advantageous).
• Technical writing and controlled documentation experience.
• Familiarity with design controls and product/software lifecycle processes.

What we offer

• Permanent full‑time position within a global med‑tech company.
• Opportunity to work on innovative medical devices and SaMD.
• Exposure to global quality systems, regulatory requirements and cross‑functional projects.