Quality Assurance Manager – QMS & Audit Readiness (IVD)

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

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