Quality Assurance Specialist – Medical Devices

About the role

We are looking for a Quality Assurance Specialist to join our fast‑growing medical‑device team in Nedlands. You will play a key role in ensuring our intra‑operative imaging tools meet the highest quality and regulatory standards.

Key responsibilities

• Prepare, review and update quality documentation, procedures and work instructions.
• Manage non‑conformances and drive corrective and preventive actions (CAPA) to closure.
• Support internal, supplier and external audits and ensure audit findings are addressed.
• Collaborate with engineering, manufacturing, clinical and regulatory teams to maintain compliance with GMP and relevant standards.
• Monitor quality metrics, conduct risk‑based assessments and contribute to continuous‑improvement projects.
• Provide quality training and guidance to staff across functions.

Required profile

• Strong foundation in Quality Assurance/Quality Control within a regulated environment.
• Experience developing, implementing and improving Quality Management Systems.
• Good knowledge of GMP principles applied to medical‑device production.
• Hands‑on experience planning and conducting quality audits.
• Bachelor’s degree in engineering, life sciences, quality or related discipline, or equivalent experience.
• Familiarity with medical‑device regulations such as ISO 13485, ISO 14971 and FDA requirements is highly desirable.
• Excellent analytical, documentation and problem‑solving abilities with a detail‑oriented approach.
• Ability to work effectively on‑site in cross‑functional teams and manage multiple priorities.

Required skills

• Quality Management System (QMS) development and maintenance
• Good Manufacturing Practice (GMP) implementation
• CAPA management
• ISO 13485 compliance
• ISO 14971 risk management
• FDA regulatory knowledge
• Quality auditing
• Risk assessment