ISO 13485 QA Leader for SaMD - Build Quality In

Lyrebird Health; Melbourne; Vor Ort; AUD 120.000 - 170.000; Vollzeit

Zusammenfassung

Lyrebird Health in Melbourne is seeking a QA Manager to own the QMS across Australia and the UK, guiding the path to ISO 13485 certification in H1 2027.

This is a build role: you’ll embed design controls and risk management with our engineers and clinicians, audit-ready by design, and drive regulatory excellence in SaMD products.

You’ll shape a scalable quality system that protects patients while enabling fast software iteration.

Qualifikationen

• Deep experience applying quality and regulatory requirements to medical devices or SaMD in product development.
• Interpret ISO 13485 and ISO 14971 for software products, not rote.
• Proven track record leading internal or external audits to clean results.
• Experience owning an end-to-end eQMS including Technical Files and DHF.
• Experience managing quality across full product lifecycle including post-market activities.

Aufgaben

• 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.

Kenntnisse

Quality management leadership

ISO 13485 / ISO 14971 knowledge

Audits & regulatory initiatives

eQMS end-to-end ownership

Software medical devices experience

Jobbeschreibung

Lyrebird Health in Melbourne is seeking a QA Manager to own the QMS across Australia and the UK, guiding the path to ISO 13485 certification in H1 2027.

This is a build role: you’ll embed design controls and risk management with our engineers and clinicians, audit-ready by design, and drive regulatory excellence in SaMD products.

You’ll shape a scalable quality system that protects patients while enabling fast software iteration.