QA Manager

The role

You will own the Quality Management System across Australia and the UK and lead the company to ISO 13485 certification in H1 2027. You will design and implement quality processes, manage the eQMS, and embed design controls and risk management into engineering and clinical workflows.

What you will do

• Own the path to ISO 13485 certification in H1 2027
• Take ownership of the Quality Manual
• Ensure eQMS processes have clear accountability for maintenance, document control, and governance
• Design and implement post-market surveillance for a SaMD product
• Lead the first Management Review with senior leadership
• Run internal self-audits ahead of certification
• Embed design controls and risk management into engineering and clinical teams

Required qualifications

• Deep experience applying quality and regulatory requirements to medical devices, SaMD or diagnostics inside product development teams
• Working knowledge of ISO 13485 and ISO 14971
• Track record of leading internal or external audits and quality system initiatives through to a clean result
• Experience owning an eQMS end to end including implementation, governance, training, document control and continuous improvement
• Experience managing quality across the full product lifecycle including design and development controls, risk management, post-market activities and regulatory change assessments

Nice to have

• Working knowledge of IEC 62304 and medical device cybersecurity requirements
• Start-up or scale-up experience
• Experience running a QMS across more than one jurisdiction

About the company

Lyrebird turns real clinical conversations into accurate notes through ambient real time document creation, intelligent document management and clinical workflow automation. The company is growing across Melbourne, the UK, and Asia.