QA Manager

Lyrebird Health

. Own the path to ISO 13485 certification in H1 2027, from readiness planning through to a successful certification audit .

Posted 10/28/2026full-timeMelbourne • AustraliaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing Quality Management Systems (QMS) for medical devices, ensuring compliance with ISO 13485 and ISO 14971 standards. Proven ability to lead audits, implement governance, and maintain documentation throughout the product lifecycle.

Highest-signal resume keywords

ISO 13485Quality Management System (QMS)Internal AuditsPost-Market SurveillanceRegulatory Requirements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ManagementDocument ControlRisk ManagementTechnical FilesDesign History RecordsEQMS ImplementationContinuous ImprovementPost-Market ActivitiesRegulatory Change AssessmentsIEC 62304

Soft Skills

LeadershipAccountabilityCollaboration

Industry Keywords

SaMDMedical DevicesDiagnosticsCybersecurity RequirementsStart-Up ExperienceScale-Up Experience

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

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 the eQMS has clear accountability for ongoing maintenance, document control and governance
Design and implement post-market surveillance for a SaMD product
Lead the first Management Review with senior leadership
Run internal self-audits ahead of certification
Embed design controls and risk management into engineering and clinical team processes
Serve as the management-appointed Quality delegate and Quality Management Representative
Own the Quality Management System across Australia and the UK

Requirements

What you’ll need

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
Track record of leading internal or external audits and quality system initiatives through to a clean result
Experience owning an eQMS end to end, including implementation, governance, training, document control and continuous improvement
Experience with Technical Files, Design History Records and post-market records
Experience managing quality across the full product lifecycle, including design and development controls, risk management, post-market activities and regulatory change assessments
Working knowledge of IEC 62304 and medical device cybersecurity requirements is nice to have
Start-up or scale-up experience is nice to have
Experience running a QMS across more than one jurisdiction is nice to have
Right to work in Australia on an ongoing basis without requiring visa sponsorship now or in the future

Benefits

Comp & perks

The company aims to provide a safe, supported, and inclusive workplace
Encouragement for applicants from underrepresented backgrounds in tech