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.
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QA Manager in Melbourne employer: present of AI
Neara is an exceptional employer for AI Product Engineers, offering a dynamic work culture that fosters innovation and collaboration. With a focus on meaningful projects that enhance safety and reliability in critical infrastructure, employees benefit from hands-on experience with cutting-edge AI technologies while enjoying ample opportunities for professional growth and development. Located in a vibrant tech hub, Neara provides a supportive environment where engineers can thrive and make a real impact in the energy sector.
