QA Manager: Clinical AI Quality, eQMS & ISO 13485 Lead

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

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.