QA Manager - Quality Management System (ISO 13485)

About the role

Lyrebird, a clinical AI company that turns real clinical conversations into accurate notes, is hiring a QA Manager to own its Quality Management System across Australia and the UK. As the management-appointed Quality delegate and Quality Management Representative, you will take the QMS to audit-ready and keep it there while the company scales. The goal is ISO 13485 certification in H1 2027; this is described as a build role, not a maintenance one.

Key responsibilities

• Own the path to ISO 13485 certification, from readiness planning through to a successful audit
• Take ownership of the Quality Manual and ensure every eQMS process has clear accountability for maintenance, document control and governance
• Design and implement post-market surveillance fit for a SaMD product that updates at software speed
• Lead the first Management Review with senior leadership
• Run internal self-audits ahead of certification
• Embed design controls and risk management into how engineering and clinical teams build

Required profile

• Deep experience applying quality and regulatory requirements to medical devices, SaMD or diagnostics in product development teams
• Track record of leading audits and quality system initiatives to a clean result
• Experience owning an eQMS end to end, including Technical Files, Design History Records and post-market records
• Experience managing quality across the full product lifecycle, including design controls, risk management and regulatory change assessments
• Nice to have: IEC 62304 and cybersecurity knowledge, start-up or scale-up experience, and having run a QMS across more than one jurisdiction

Required skills

• Working knowledge of ISO 13485 and ISO 14971, applied to a software product
• eQMS implementation, governance, training and document control