About the role The Quality Assurance Associate at OncoRes Medical plays a key role in maintaining and strengthening our Quality Management System, and in delivering Quality Assurance projects and operational activities across product development and manufacturing. This is a 12-month fixed term contract, with the possibility of extension, offering the opportunity to make a meaningful and visible contribution within a collaborative, high-growth medical device environment.

Key responsibilities

As a member of the Quality team, you will take ownership of a diverse range of QA activities and partner with colleagues across the organisation to strengthen quality culture, maintain compliant operations, and drive continuous improvement within the Quality Management System (QMS).

- Own and maintain QMS compliance across product development and manufacturing, reporting to the Head of Quality

- Lead the management of non-conformances, CAPAs, deviations and change control, including root cause investigation and effectiveness checks

- Provide QA support to design and development activities, including design controls, risk management and design history file review

- Develop, review and approve quality procedures, work instructions and records, ensuring alignment with ISO 13485 and applicable regulatory requirements

- Assist with planning and conducting internal and supplier audits, support the preparation of audit documentation, and help coordinate activities for external audits and regulatory inspections

- Review manufacturing records and support supplier quality management activities

- Support quality and regulatory activities, including support for clinical trials

- Analyse and trend quality data, and prepare metrics and reports to support management review

- Drive continuous improvement initiatives through process performance assessment





- Provide guidance and training on quality requirements across the business, and support the development of other team members

- Assist with any other QC activities as required

About you

- A degree in engineering, science, or a related discipline, with 3+ years of relevant quality assurance experience, ideally within the medical device industry

- Demonstrated experience working within ISO 13485 and/or cGMP quality management systems, including hands-on ownership of non-conformances, CAPAs, change control and document control

- Working knowledge of ISO 14971 risk management and design controls; familiarity with FDA 21 CFR Part 820 requirements is highly regarded

- Strong analytical and problem solving skills, with the ability to work autonomously and take ownership of outcomes, as well as collaboratively

- Well developed written and verbal communication skills, with the ability to influence and collaborate constructively across teams

- Strong organisational skills, including the ability to plan, prioritise, and coordinate multiple deliverables; a hands on approach, flexibility, initiative, and an enthusiastic can-do attitude are essential
- An innovative, solution-focused mindset, with the ability to develop practical and timely responses to technical challenges
- A qualified and positive approach in all interactions, with a strong work ethic, self discipline, and willingness to support others in achieving shared goals





- Candidates must have full working rights in Australia

About us

OncoRes Medical was founded at the intersection of medicine, science and humanity to improve the accuracy of breast-conserving surgery and eliminate the physical, psychological and economic burdens associated with repeat operations. Our unique, informal culture champions vision, restlessness and humanity. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership.

We have a shared passion to work restlessly, pioneering change to re-imagine the world, while remaining grounded in our commitment to science and quality. Our passion for helping patients and their needs remain our primary focus. We believe that all breast cancer patients deserve the opportunity to move beyond their breast cancer surgery knowing that all the cancer has been removed, the first time.

In everything we do, we are thinking about how we can inch closer to a world free from re-excisions... We are going BEYOND BREAST CANCER.

Benefits

- A competitive remuneration package
- A flexible, supportive, and enjoyable workplace where we recognise that life extends beyond work
- A rare opportunity to work closely with world-class colleagues and mentors who bring deep experience across medical device development and commercialisation, in a collaborative environment where every voice is valued and professional growth is encouraged

To Apply

Please submit a cover letter and CV addressed to Malcolm Jones, Head of Quality outlining your suitability for the role. Only applications submitted via SEEK will be considered. Closing date for receipt of applications is Tuesday 3 November 2026.

We are not accepting applications from recruitment agencies for this role.

📌 Quality Assurance Associate (Nedlands)
🏢 OncoRes Medical
📍 Nedlands