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 *****:**** 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 ISO*****:****, EU IVDR, MDSAP, and US FDA QSR requirements
Own internal document control, change control, design controls, and risk management (ISO *****) 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 ISO***** / EU IVDR quality audits
Robust working knowledge of ISO *****:****, ISO *****, 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 ISO*****/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.
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📌 Quality Assurance Manager (Sydney)
🏢 OrthoDx
📍 Sydney