Location: Carlton VIC, Hybrid/flexible available

Type: Full-Time (Flexible, part-time or reduced hours available)

About MX3 Diagnostics

MX3 Diagnostics is a health technology company with a focus on non-invasive, point-of-care diagnostics, providing our customers with a simple and reliable way of tracking informative health biomarkers.

MX3 devices are used by customers worldwide across many industries, including mining, professional sports, emergency services, and military.

About the Role

We are seeking a Quality Systems Manager to lead and evolve our Quality Management System (QMS) in alignment with international standards. This is a pivotal leadership role reporting to senior management, with a direct impact on our compliance, product excellence, and global regulatory readiness (TGA, FDA, CE). You'll be the driving force behind continuous improvement and quality assurance across our organisation.

Key Responsibilities

Develop, maintain, and enhance MX3's QMS in compliance with ISO 13485, FDA QSR, and other applicable standards

Own and manage core QMS elements:

Document control & change management

CAPA & non-conformance handling

Internal/external audits

Training systems

Supplier and distributor quality oversight

Lead audit programs and readiness for certification (TGA, FDA, CE)

Report on key quality KPIs to internal stakeholders and external regulatory bodies

Serve as the internal expert on regulatory requirements, guiding best practice

Lead, mentor and develop members of Quality Assurance and Regulatory Affairs teams

Promote a company-wide culture of quality and environmental responsibility

What we are looking for:

Proven experience managing an ISO 13485-compliant QMS (essential)

Experience in a start-up or scale-up environment (highly desirable)

Experience with IVD medical device regulation (highly desirable)

Scientific or technical academic background

4+ years in Quality roles, including 2+ years in leadership

Excellent communication and cross-functional collaboration skills

High attention to detail with strong analytical and problem-solving ability

Proficiency in MS Office and quality reporting tools

A proactive mindset and drive for continuous improvement

How to Apply: Click on "Quick Apply" and upload a Resumé and cover letter addressing the selection criteria.

Must have unrestricted work rights in Australia