Company Description
Compumedics, established in 1987 and headquartered in Melbourne, Australia, is a global leader in developing and manufacturing diagnostic technologies for sleep disorders, neurophysiology, and cardiology. The company holds a significant market share in Australia and a growing presence in the US, Europe, and Asia. Its products, including advanced diagnostic systems and software platforms, are distributed in over 50 countries. Compumedics has received numerous prestigious awards for its technological innovations, market expansion strategies, and contributions to the healthcare industry.
Role Description
This is a full-time, on-site role for a Quality Engineer located in the Greater Melbourne Area. The Quality Engineer will be responsible for ensuring product quality through rigorous quality assurance and control processes. Daily tasks include implementing quality management systems, analysing and improving product quality, and supporting continuous improvement initiatives to meet compliance and customer expectations.
Reporting to the QA Manager, you will be required to have:
* Demonstrated understanding and working knowledge of ISO13485:2016
* Knowledge of FDA QSR, MDSAP & EU-MDR will be plus
* Coordinate, manage and organise the task with internal as well as external stakeholders
* At least two years' experience in Quality Engineering in Medical Devices
* Experience in developing Design History File and Technical File documentation for medical devices
* Ability to assist in overseeing the Documentation System and ensure compliance to GMP / GDP and ISO13485 for the CAPA, non-conformance, complaint handling, risk management and change request programs
* Ability to conduct/ assist with root cause analysis
* Able to participate in internal and supplier audits (Certified trained internal auditor skills would be an advantage)
* Advanced computer skills
* Excellent attention to detail and highly motivated.