Senior Quality Engineer – Medical Devices

Perth | In office | Biosensor Technology

Help bring innovative medical technology from development into clinical use.

Lead Group is partnering with an Australian medical technology company developing novel biosensor technology to improve outcomes for mothers and babies during childbirth.

As the business prepares for its next clinical and regulatory milestones, we are seeking a Senior Quality Engineer to work alongside engineers, scientists and manufacturing teams, turning product requirements into reliable processes and robust quality evidence.

The opportunity

This is a practical engineering role, with approximately 70% focused on quality engineering and 30% on quality assurance and QMS activities.

You will write and execute validation protocols, support design transfer, qualify suppliers and help ensure devices are ready for development, pre-clinical and clinical use. Expect regular time in the cleanroom and on the manufacturing floor.

What you’ll do

- Write, review and execute product verification and validation protocols and reports, maintaining traceability to requirements.
- Plan and run equipment and process IQ/OQ/PQ across activities such as dispensing, coating, curing, assembly and sterilisation.
- Validate test methods and measurement systems, applying Gage R&R;, capability analysis and statistical process controls.
- Qualify and audit suppliers, establish incoming inspection requirements and resolve supplier quality issues.
- Lead nonconformance investigations, CAPA and root-cause analysis.




- Maintain risk-management documentation, including design and process FMEAs.
- Support eQMS administration, change control, internal audits and inspection readiness.
- Review manufacturing records and support product release under delegated authority.

What you’ll bring

- A degree in engineering or science.
- At least five years of quality engineering experience in medical devices under ISO 13485.
- Demonstrated ownership of validation protocols—from planning and execution through to analysis and reporting.
- Working knowledge of design controls, ISO 14971 and FDA QMSR requirements.
- Experience in supplier quality, CAPA and structured problem-solving.
- Practical statistical skills, including process capability, SPC and measurement-system analysis.

Experience with biosensors, microfluidics, cleanroom manufacturing, electronics or chemical processes would be highly regarded. ISO 13485 auditor qualifications and Lean Six Sigma training are also desirable.

Why consider this role?

- Contribute to technology addressing a meaningful clinical need.
- Take ownership across product development and manufacturing.
- Work closely with a multidisciplinary team where your decisions directly influence quality and clinical readiness.
- Help build practical quality systems as the company grows.

We are looking for someone who holds the quality line, explains the reasoning and helps teams find a workable, compliant path forward.

The position is based on-site in Perth.

📌 Senior Quality Engineer – Medical Devices (Perth)
🏢 Lead Group
📍 Perth