Quality Assurance Specialist

https://au.seek.com/job/92397160?ref=direct-share-cm-ui

Company Description OncoRes Medical is a medical device company developing an intraoperative imaging tool that converts a surgeon’s sense of touch into high-resolution microscale images, with the aim of improving surgical accuracy and reducing complication rates. Founded in 2016, the company is funded by the Medical Research Commercialisation Fund and focuses on patent-protected technologies with strong translational potential. OncoRes collaborates closely with leading researchers at the University of Western Australia, the Harry Perkins Institute of Medical Research, and breast cancer surgeons from the Western Australian Department of Health. Team members join a mission-driven environment at the intersection of engineering, clinical research, and surgical innovation. Additional information is available at www.oncoresmedical.com or via info@oncoresmed

ical.com.

Role Description This is a full-time, on-site Quality Assurance Specialist role based in Nedlands, WA. The Quality Assurance Specialist will support the development, manufacture, and validation of OncoRes’ medical devices by maintaining and improving the quality management system. Day-to-day responsibilities include preparing, reviewing, and updating quality documentation and procedures, managing nonconformances and corrective and preventive actions (CAPA), and supporting internal and external audits. The role involves collaborating with engineering, manufacturing, clinical, and regulatory teams to ensure compliance with applicable standards, regulations, and Good Manufacturing Practice (GMP) requirements. The Specialist will also monitor quality metrics, perform risk-based quality assessments, contribute to continuous improvement initiatives, and provide quality training and guidance to team members.

Qualifications

• Strong foundation in Quality Assurance and Quality Control, with experience applying these practices in a regulated environment.
• Experience with Quality Management systems, including development, implementation, maintenance, and continuous improvement of QMS processes.
• Knowledge of Good Manufacturing Practice (GMP) principles and their application in medical device or related industries.
• Experience in Quality Auditing, including planning, conducting, and responding to internal and supplier audits.
• Bachelor’s degree in engineering, life sciences, quality, or a related discipline, or equivalent relevant experience.
• Familiarity with medical device regulations and standards (e.g., ISO 13485, ISO 14971, FDA requirements) is highly desirable.
• Strong analytical, documentation, and problem-solving skills, with attention to detail and a structured approach to risk and CAPA management.
• Ability to work effectively on-site in a cross-functional team, communicate clearly with diverse stakeholders, and manage multiple priorities in a fast-paced environment.