Quality Assurance Manager – MedTech Manufacturing

About the role

This is a hands‑on leadership position within a fast‑growing Australian MedTech company developing biosensor technology for maternal and fetal health. You will guide the transition from R&D to commercial manufacturing while ensuring quality excellence across the organisation.

Key responsibilities

• Lead and maintain the Quality Management System (QMS) in line with ISO 13485 and GMP.
• Provide oversight for QA, QC, validation and manufacturing quality activities.
• Manage cleanroom operations, including environmental monitoring and contamination control.
• Support process development, scale‑up, and continuous improvement initiatives.
• Drive CAPA, NCR, deviation, change control and risk management processes.
• Oversee validation activities (IQ/OQ/PQ, process validation, Validation Master Plan).
• Prepare for audits and support regulatory inspections.
• Mentor the Quality team and promote a strong quality culture.

Required profile

• Significant experience in MedTech, pharmaceutical, biotech or other highly regulated manufacturing environments.
• Proven leadership of QA/QC or quality teams.
• Strong problem‑solving, communication and stakeholder‑management abilities.
• Experience with scale‑up or fast‑paced manufacturing is highly regarded.

Required skills

• ISO 13485
• GMP
• Cleanroom operations
• Process validation (IQ/OQ/PQ)
• CAPA management
• NCR handling
• Risk management
• Audit readiness
• Regulatory inspection support

What we offer

• High‑visibility role reporting to senior leadership.
• Collaborative, purpose‑driven culture.
• Opportunity to influence manufacturing quality and operational growth.
• Hybrid work flexibility after probation.