QA Manager

present of AI; Melbourne; Hybrid; AUD 120,000 - 180,000; Full time

Job summary

Lyrebird Health seeks a quality leader to build and operate a QMS for a clinical AI product across two countries, guiding it through ISO 13485 certification. The role demands hands-on application of medical device quality rules within software teams and ownership of end-to-end eQMS.

You will drive audits to a clean result and ensure risk management keeps pace with rapid software updates, maintaining patient safety and regulatory compliance.

Qualifications

• Hands-on experience applying medical device quality rules inside software product teams.
• Experience leading audits to clean results.
• Own an electronic quality management system end to end.

Responsibilities

• Build and run a quality management system for a clinical AI product.
• Lead audits and drive ISO 13485 certification.
• Maintain post-market surveillance and risk management aligned with software speed.

Skills

Quality management

ISO 13485

ISO 14971

IEC 62304

Audits

Regulatory for medical software

Risk management

eQMS ownership

Education

Degree in engineering/biomedical

Job description

This role asks someone to build and run a quality management system for a clinical AI product across two countries, then carry it through ISO 13485 certification. A strong candidate has hands on experience applying medical device quality rules inside software product teams, owns an electronic quality system end to end, and has led audits to a clean result. The person needs judgement to tell a system that protects patients from one that only makes paperwork.

How it fits the AI era

The product is software that changes quickly, so quality work has to keep pace with frequent releases rather than freeze them. AI changes the pace and the need for post market monitoring, since the tool turns live consultations into records that shape care. What stays human is the judgement about risk, the accountability for decisions, and the discipline of finding gaps before an auditor does.

How it builds AI experience

Working here gives direct exposure to quality and regulatory practice for a clinical AI scribe that writes into patient records, including post market surveillance for a product that updates at software speed. Someone can build this by learning ISO 13485 and ISO 14971 applied to software, plus design controls and risk management for AI driven clinical tools. Familiarity with IEC 62304 and device cybersecurity would strengthen the fit.

Worth showing

• ISO 13485 certification lead
• eQMS ownership end to end
• Audit leadership clean results

This is our own read, written from the employer's posting and the company's Spotlight. The employer's posting is the source of truth for the role.

About Lyrebird Health

An AI scribe built directly into Australia's most-used GP software, auto-filling care plans from the consultation rather than just writing a note.