Quality Assurance Manager

OrthoDx Pty Ltd; Sydney; On-site; AUD 150,000 - 210,000; Full time

Job summary

OrthoDx Pty Ltd, based in Sydney, seeks a Quality Manager to lead hands-on QA/QMS operations across ISO 13485:2016, EU IVDR, MDSAP, and FDA QSR frameworks. You will drive audits, CAPAs, document control, and risk management to ensure robust compliance as the company expands globally in orthopedics and IVD diagnostics.

Reporting into the leadership team, you will partner with regulatory and technical functions to maintain a state-of-the-art QMS, prepare for upcoming audits, and embed continuous

Qualifications

• 3-5+ years of hands-on QA/QMS management in IVD/medical devices.
• Experience preparing for MDSAP and ISO13485 / EU IVDR audits.
• Strong knowledge of ISO 13485:2016, ISO 14971, EU IVDR, and FDA QSR.
• Experience with document control, CAPAs, and change control.

Responsibilities

• Lead preparation, execution, and remediation for QMS audits (MDSAP and EU IVDR).
• Maintain and optimize QMS under ISO13485:2016, EU IVDR, MDSAP, and FDA QSR.
• Own internal document control, change control, design controls, and risk management (ISO 14971).
• Drive CAPAs and root-cause investigations to resolve quality issues.
• Plan and execute internal QMS audits for readiness for external inspections.
• Oversee internal product complaint handling and post-market quality metrics.
• Collaborate with technical and regulatory teams to separate internal quality from submissions.

Skills

Quality Assurance

QMS management

Internal audits

CAPA

Document control

Change control

Risk management

Root cause analysis

Lead Auditor

Job description

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

Strong 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.