- $126,000 to $132,000 + up to 17% Superannuation
- Fixed-term until 31 December 2026
- Heidelberg/Hybrid Location, 0.8 FTE Considered
About Us
The Australian Epilepsy Project (AEP) is a national-scale research program funded by the Medical Research Future Fund (MRFF) Frontiers Initiative and is made possible through the combined support of The Florey and other institutions. Our mission is to transform epilepsy care through world-leading diagnostics and accelerate the next wave of health innovation using big data, machine learning, and entrepreneurship. You can learn more about the AEP in this short video.
About The Role
As we transition our innovative digital health platform towards commercialisation, we're seeking an experienced Quality Manager to establish and lead the Quality Management System (QMS) that will underpin our Software as a Medical Device (SaMD) portfolio.
This is a unique opportunity to join a nationally significant initiative at a pivotal stage of growth and play a leading role in building a quality and compliance framework from the ground up.
Reporting to the Commercial Lead, you will be responsible for designing, implementing, and operating an ISO 13485-compliant Quality Management System that supports the AEP's digital health products and future regulatory ambitions.
Working closely with Regulatory Affairs, Technology, Clinical and Executive teams, you'll embed quality into every stage of product development while establishing the systems, processes, and culture needed to support compliance, innovation, and commercial growth.
This is a hands-on leadership role suited to someone who thrives in a fast-paced environment and enjoys building fit-for-purpose quality systems rather than maintaining established ones.
What You'll Do
Quality Management System
- Build, implement and maintain an ISO 13485-compliant QMS.
- Establish document control processes, SOPs and quality records.
- Lead change control processes and quality governance.
- Implement risk management frameworks aligned to ISO 14971.
- Support software lifecycle quality processes in accordance with IEC 62304.
- Maintain quality metrics and provide reporting to executive leadership.
Audits, CAPA & Compliance
- Lead the CAPA program and non-conformance management.
- Manage complaints, incidents and post-market surveillance processes.
- Plan and conduct internal audits.
- Coordinate external audits and regulatory assessments.
- Conduct supplier qualification and audit activities.
Regulatory Support
- Partner closely with Regulatory Affairs on TGA submissions and compliance activities.
- Maintain audit-ready documentation and technical records.
- Support cybersecurity and data privacy compliance initiatives.
Quality Culture
- Deliver quality and compliance training across the organisation.
- Champion continuous improvement and quality-by-design principles.
- Foster a culture where quality enables innovation and growth.
About You
You are an experienced quality professional who understands both the rigour of regulated environments and the agility required in a growing digital health organisation.
You'll bring:
Essential
- Experience building or substantially implementing an ISO 13485-compliant QMS.
- Background in medical devices, digital health, SaMD, biotechnology or related industries.
- Hands-on experience with CAPA, audits, complaint handling and incident management.
- Knowledge of ISO 14971 risk management and IEC 62304 software lifecycle standards.
- Familiarity with TGA medical device requirements and post-market obligations.
- Strong documentation, stakeholder engagement and training skills.
- Ability to work independently and drive multiple quality initiatives simultaneously.
Desirable
- MDSAP, EU MDR or FDA quality framework exposure
- Cybersecurity risk management experience.
- Experience in research, academic or start-up environments.
- ISO 13485 Lead Auditor certification.
- Digital health, neurology or epilepsy sector experience.
How to Apply
If you feel this role is right for you, please apply with a Cover Letter outlining your interest and experience and your Resume. Please note that you are not required to respond to the criteria in the Position Description.
Applications close 14 August 2026
Visa sponsorship is not available for this position. This role requires current valid work rights for Australia. The preferred applicant for this job will be asked to consent to a police check.
Why Join Us?
- Be part of a purpose-driven team making a tangible impact.
- Work in a collaborative environment that values innovation and inclusivity.
- Collaborate with leading researchers, clinicians, and innovators
Working at the Florey:
The Australian Epilepsy Project is made possible through the combined support of The Florey and other institutions. With a 50-year history, the Florey is the largest brain research centre in the Southern Hemisphere, with teams of researchers dedicated to building knowledge on a range of neurological and psychiatric conditions. Learn more about our Research Impact.
Our reputation for innovative research and our position as the leading brain research institute in the Southern Hemisphere attracts the best and brightest. Connected by our shared mission to improve lives through brain and mental health research, The Florey provides a dynamic and inspiring workplace where you can develop your career. We have a deep commitment to diversity and creating an inclusive workplace culture where our people can excel and thrive and support our exceptional people to make a positive impact on the local and global research community.
Learn more about working at the Florey here.
For enquiries, please contact our People and Culture Team on [email protected].
