About the role

The Quality Manager is responsible for the hands-on management, maintenance, and continuous improvement of OrthoDx's Quality Management System (QMS) in accordance with ISO 13485:2016 and global regulatory standards. As OrthoDx expands globally as a diagnostics company specializing in orthopedics and IVD diagnostic tests, this role is critical for establishing robust internal quality processes, preparing the organization for upcoming MDSAP and EU IVDR QMS audits, and absorbing internal quality workloads to streamline operations.

Key responsibilities

- Lead comprehensive preparation, execution, and remediation for upcoming QMS audits, specifically targeting MDSAP and EU IVDR quality system requirements

- Maintain and optimize the QMS under ISO13485:2016, EU IVDR, MDSAP, and US FDA QSR requirements

- Own internal document control, change control, design controls, and risk management (ISO 14971) to ensure seamless operational flow

- Drive root cause investigations, corrective actions, and preventive actions (CAPAs) efficiently to resolve internal quality issues

- Plan, schedule, and execute internal QMS audits to ensure continuous compliance and readiness for external notified body inspections

- Oversee internal product complaint handling, customer feedback tracking,



and post-market quality metrics

- Partner closely with technical and regulatory teams to cleanly separate internal quality execution from external submission documentation

About you

- Minimum 3-5+ years of hands-on Quality Assurance / QMS management experience within the In-Vitro Diagnostics (IVD) or medical device industry

- Demonstrated, practical experience successfully preparing for and managing MDSAP and ISO13485 / EU IVDR quality audits

- Robust working knowledge of ISO 13485:2016, ISO 14971, EU IVDR, and US FDA.

- Proven ability to take ownership of day-to-day QMS workloads, document control, and CAPAs independently

- Lead Auditor certification for ISO13485/MDSAP (desirable)

- Direct experience working with In-Vitro Diagnostic (IVD) and orthopedic medical devices

- Exceptional attention to detail regarding document control, audit trails, and quality records

- Capable of driving quality initiatives autonomously with minimal friction

- Able to work effectively across technical and cross-functional teams to keep milestones on track

About us

OrthoDx is a rapidly expanding diagnostics innovator based in Sydney, specializing in orthopedics and IVD diagnostic tests.

📌 Quality Assurance Manager (Macquarie Park)
🏢 OrthoDx
📍 Macquarie Park