Company Description
Ferronova is on a mission to ensure everyone with cancer receives the surgery and radiotherapy they need, no more, no less. To see this mission come to fruition, Ferronova is commercialising novel products that include medical devices, nanoparticles, and machine learning software, to be used in image guided cancer surgery.
Role Description
This is a full‐time, on‐site role based in Adelaide, South Australia. The Quality Associate supports daily quality operations and maintains the Quality Management System in alignment with ISO 13485, FDA QMSR, EU MDR, PIC/S, and cGMP requirements. This role assists with documentation control, nonconformance and CAPA processes, change control, training, and production quality activities, performs internal and vendor audits and contributes to continuous improvement efforts that uphold product quality, safety, and regulatory compliance. Ideal candidates will have experience in both medical devices and pharmaceuticals, or be experienced in one sector and eager to embrace learning the requirements of the other.
Qualifications/Requirements
* Demonstrated proactive mindset with strong ownership and accountability for outcomes.
* Minimum of 3 years' experience in quality management and/or regulatory compliance for class III medical devices and/or pharmaceuticals
* Understanding of GMP principles (PIC/S, FDA 21 CFR Parts 210/211), ISO 13485 and risk management principles (ISO 14971 exposure advantageous) and regulatory frameworks in the USA, Australia, and Europe.
* Strong skills in Quality Control and Quality Management, ensuring standards and processes are maintained.
* Proficiency in Quality Assurance and Quality Auditing to support compliance and performance objectives.
* Demonstrated Analytical Skills for evaluating data, identifying trends, and implementing process improvements.
* Ability to work as part of a cross‐functional team and independently, with good organisation and time management skills to ensure timely delivery of activities.
* Attention to detail, strong problem solving skills, and ability to work with precision in a regulated environment.
* Strong written and verbal communication skills.
Applications close on 30 April 2026
#J-18808-Ljbffr