Quality Assurance Team Lead (Medical Device / ISO 13485)
Salary range: 130,000–150,000 AUD
Pearson Carter are currently working with a VC-backed Australian MedTech company developing advanced biosensor technology within a highly regulated medical device environment. Their mission is to transition from R&D into scalable manufacturing while maintaining the highest standards of safety, quality, and compliance.
Due to growth, the company is hiring a Quality Assurance Team Lead to own and develop the Quality function, lead a small team, and serve as the ISO 13485 Management Representative and EU MDR compliance lead.
Responsibilities
* Lead and develop the Quality Management System (ISO 13485, GMP, EU MDR compliance)
* Own QA/QC, validation, CAPA, NCR, change control, and audit readiness
* Oversee manufacturing and cleanroom quality processes
* Lead validation strategy (IQ/OQ/PQ, VMP) and design transfer into production
* Advise senior leadership on quality strategy and regulatory requirements
* Drive process improvement and reduce manufacturing variability
* Lead and mentor QA/QC and validation team members
Qualifications
* Strong ISO 13485/medical device quality experience
* Background in QA/QC, validation, and manufacturing environments
* Experience leading quality teams in regulated industries
* Strong knowledge of GMP, CAPA, NCR, audits, and change control
* Ability to influence at senior/executive level
* Strong medical device and regulated manufacturing background
* Must have relevant working rights in Australia
Location
Perth, Australia
Benefits
Long-term opportunity within a growing MedTech business.
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