QA Manager

Description

Every day in Australia, 10 people die from preventable medical errors. Not from incurable diseases, but from misdiagnosis, missed information, and clinicians making decisions under impossible pressure. At the centre of that failure is a doctor spending 40% of their day on paperwork instead of patients. Lyrebird is fixing that.

We turn real clinical conversations into accurate notes, automatically, backed by ambient real time document creation, intelligent document management and clinical workflow automation, native patient data integrations across siloed health systems, and a patient and clinical communications layer. Thousands of clinicians across multiple disciplines use Lyrebird every day in environments where accuracy, safety, and time matter deeply. We're growing fast across Melbourne, the UK, and Asia, and there's a finite window right now to set the standard for clinical AI in Australia before anyone else does.

Responsibilities

• We ship software fast. We also sit inside real patient consultations. Making those two things coexist safely is your job. You'll own our Quality Management System across Australia and the UK, and lead us to ISO 13485 certification in H1 2027. As our management-appointed Quality delegate and Quality Management Representative, you'll take the QMS to audit-ready and keep it there as we scale. This is a build role, not a maintenance one.
• You've seen enough quality systems to know which ones protect patients and which ones just generate paperwork, and you have a clear point of view on the difference. You don't wait for a gap to surface in an audit: you find it, call it out, and fix it. You're at home working alongside engineers who ship fast and clinicians who care about safety above all else, and you build a system that serves both. Fast-moving software doesn't make you nervous, it makes you curious about how to build quality in from day one.
• Own the path to ISO 13485 certification in H1 2027, from readiness planning through to a successful certification audit
• Take ownership of the Quality Manual and make it something the business actually runs on
• Ensure every process documented in our eQMS has clear accountability for its ongoing maintenance, document control, and governance that stand up to an auditor's scrutiny
• Design and implement post-market surveillance that's fit for purpose for a SaMD product that updates at software speed
• Lead our first Management Review with senior leadership, setting the rhythm for how quality is reported and decided on at the top
• Run internal self-audits ahead of certification, finding the gaps before an external auditor does
• Embed design controls and risk management into how our engineering and clinical teams build, so quality is designed in rather than bolted on
• What you'll bring
• 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, and the judgement to interpret them for a software product rather than apply them by rote
• A track record of leading internal or external audits and quality system initiatives through to a clean result
• Experience owning an eQMS end to end: implementation, governance, training, document control and continuous improvement, including the Technical Files, Design History Records and post-market records that live within it
• Experience managing quality across the full product lifecycle, including design and development controls, risk management, post-market activities and regulatory change assessments

Requirements

• Working knowledge of IEC 62304 and medical device cybersecurity requirements
• Start-up or scale-up experience, where you've had to think laterally to solve complex quality and regulatory problems
• Experience running a QMS across more than one jurisdiction
• Every note Lyrebird produces ends up in a patient's record and shapes decisions about their care. The quality system you build is what lets clinicians, regulators and patients trust that, and getting it right is a direct line to safer care for thousands of people.
• We're building a team that reflects the diversity of the people who benefit from our work. We want Lyrebird to be a place where everyone feels safe, supported, and able to thrive. If you're from an underrepresented background in tech, we strongly encourage you to apply, even if you don't meet every requirement.