Quality Assurance Lead (MedTech)

TL;DR

Quality Assurance Lead (MedTech): Developing and overseeing Quality Assurance and Quality Control activities to ensure compliance with ISO 13485, GMP, and EU MDR with an accent on QMS governance and cleanroom oversight. Focus on transitioning products from R&D to scalable manufacturing and implementing robust validation strategies.

Location: Onsite in Perth, Australia

Salary: £120,000 - £150,000

Company

A multi-award-winning, VC-funded Australian MedTech company developing novel biosensor technologies for fetal monitoring.

What you will do

• Provide operational leadership of the Quality function, acting as the ISO 13485 Management Representative and PPRC under EU MDR.
• Implement and maintain the Quality Management System (QMS), overseeing document control, CAPA, and risk management processes.
• Manage cleanroom quality activities, including environmental monitoring, contamination control, and housekeeping processes.
• Oversee New Product Introduction (NPI), design transfer, and the execution of the Validation Master Plan (VMP).
• Lead preparation for internal and external audits and ensure timely closure of audit findings.
• Directly manage the quality team, handling recruitment, onboarding, and performance development.

Requirements

• Bachelor’s degree in Science, Engineering, Biotechnology, or a related discipline.
• Proven experience in medical device or similarly regulated quality environments.
• Strong working knowledge of ISO 13485, GMP principles, and QMS processes.
• Demonstrated experience overseeing QC, QA, validation, and cleanroom operations.
• Experience leading quality teams within a manufacturing environment.
• Must be based in or able to work onsite in Perth, Australia.

Nice to have

• Auditor qualification (internal or lead auditor).

Culture & Benefits

• Opportunity to work in a fast-paced VC-funded startup/scale-up environment.
• Role with significant impact on the transition from R&D to commercial manufacturing.
• Leadership position with direct influence over quality governance and regulatory compliance.