Quality Assurance Team Lead (Medical Device)

TL;DR

Quality Assurance Team Lead (Medical Device): Developing and owning the quality function for advanced biosensor technology in a highly regulated environment with an accent on ISO 13485 and EU MDR compliance. Focus on transitioning from R&D to scalable manufacturing, leading validation strategies, and managing audit readiness.

Location: Perth, Australia. Must have relevant working rights.

Salary: 130,000–150,000 AUD

Company

VC-backed Australian MedTech company developing advanced biosensor technology.

What you will do

• Lead and develop the Quality Management System based on ISO 13485, GMP, and 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.
• Lead and mentor the QA/QC and validation team members.

Requirements

• Strong experience with ISO 13485 and medical device quality standards.
• Background in QA/QC, validation, and regulated manufacturing environments.
• Experience leading quality teams in regulated industries.
• Strong knowledge of GMP, CAPA, NCR, audits, and change control.
• Must have relevant working rights for Australia.
• Ability to influence and communicate at the executive level.