Quality Assurance Manager

Quality Assurance Team Lead (Medical Device / ISO 13485), 130,000–150,000 

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, they are hiring a Quality Assurance Team Lead to own and develop the Quality function, lead a small team, and act as the ISO 13485 Management Representative and EU MDR compliance lead.

They offer an excellent salary of 130K–150K long-term opportunity within a growing MedTech business.

Get in touch if you’re looking for your next opportunity!

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

Experience:
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

Salary
They offer an excellent salary package: 130,000–150,000 AUD

Location
Perth

Applications are welcome from experienced quality professionals with strong medical device and regulated manufacturing backgrounds. Must have relevant working rights.

How to Apply
Please apply asap with your CV to be considered for this position. You can also get in touch with me on jessicab@pearsoncarter.com or (03) 7045 5354.

Pearson Carter is the Global Leader in Technology, Engineering, and Software Development Recruitment with specialist roles across the globe – www.pearsoncarter.com