• Parkville / Flexible Location | Onsite paid parking + close to public transport
• Full time position | Contracted for 12 months with potential to extend
• Join a research driven organisation | Contribute towards youth mental health About Orygen Orygen is Australia’s Centre of Excellence in Youth Mental Health and the largest translational research organisation dedicated to youth mental health in the world. For over 30 years, Orygen has led groundbreaking early intervention and developed evidence-based models of care to improve the mental health outcomes of young people aged 12-25. About The Job The Product Quality Manager (PQM) is responsible for the operational leadership, implementation and continuous improvement of Orygen Digital’s Product Quality Management System (QMS), ensuring the MOST product and associated processes meet applicable regulatory and compliance requirements, quality standards and organisational expectations. Reporting to the Governance & Regulatory Lead, Orygen Digital, you will:
• Own and enhance quality management systems that support the delivery of innovative digital mental health products and research initiatives.
• Ensure compliance with national and international quality, research and regulatory standards, including medical device and clinical research requirements.
• Lead audits, risk management, regulatory submissions and continuous improvement activities to strengthen quality and governance outcomes.
• Collaborate with cross-functional teams to integrate quality and compliance considerations throughout product development and research operations.
• Build organisational capability in quality and compliance through training, coaching and the promotion of a strong quality culture across Orygen Digital and Research.



Skills and experience The following criteria must be met for consideration for this position:
• Extensive experience in quality and regulatory management within medical device, digital health or Software as a Medical Device (SaMD) environments, with strong knowledge of ISO 13485, IEC 62304 and ISO 14971.
• Proven expertise in quality systems, audits, risk management, CAPA, regulatory compliance and product lifecycle activities, from development through to market release.
• Demonstrated ability to provide quality oversight across software and research environments, including verification, validation, post-market surveillance and regulatory reporting.
• Strong stakeholder engagement skills, with experience influencing multidisciplinary teams and embedding quality and compliance requirements into business operations.
• Excellent analytical, communication and continuous improvement capabilities, with a pragmatic approach to managing quality risks and driving organisational capability. Benefits
• $135,000 – $145,000 commensurate with skills and experience + superannuation and $15,900 in NFP salary packaging + $2,600 meals and entertainment card.
• Embrace the freedom of a hybrid work model, combining remote work with on-site collaboration.
• Tailor your work hours to balance personal commitments and professional responsibilities.
• Engage in innovative projects alongside passionate professionals across various disciplines.




• Support Orygen's mission for youth mental health and contribute to positive social change.
• Experience a workspace that was thoughtfully created with input from young people, promoting a collaborative and inclusive atmosphere.

How to apply
If you’re ready to make a difference in youth mental health and be part of a team-oriented, innovative team, apply now. For the full position description, visit https://www.orygen.org.au/getmedia/a378026f-d89c-41a0-8f97-f7be2ae9aa6c/Position-Description_Product-Quality-Manager_November-2026.pdf.aspx This is full-time position (1.0 FTE) contracted for 12 months, with the potential to extend. Applications will close on 19th November 2026 (8am), unless a suitable candidate is found sooner. Before applying at Orygen, it’s important to understand that you may encounter sensitive information related to mental health as part of your work. Being aware of this and how it could affect you is essential in deciding if this is the right chance for you. Orygen is committed to providing diverse, equitable and inclusive environments for Staff and anyone connected to Orygen. We strive to continue building a culturally safe workplace where our values underpin the way we work and our commitment to First Nations people of Australia, young people and their families, people with disabilities, LGBTIQA+ people and CALD communities. We strongly encourage applications from First Nations people. Orygen is a child-safe organisation and is committed to promoting and protecting the safety and well-being of all young people and embedding safeguarding practices into all our programs and services. All employment appointments are subject to holding a valid working with children check and successful police check.

📌 Product Quality Manager (Melbourne)
🏢 Orygen
📍 Melbourne