Quality Assurance Manager

About the role

The Quality Assurance Manager will lead the hands‑on management, maintenance, and continuous improvement of OrthoDx’s Quality Management System (QMS) in line with ISO 13485:2016 and global regulatory standards. This role is pivotal as the company expands its orthopedics and IVD diagnostic portfolio worldwide.

Key responsibilities

• Lead preparation, execution, and remediation for upcoming MDSAP and EU IVDR audits.
• Maintain and optimise the QMS under ISO 13485:2016, EU IVDR, MDSAP, and US FDA QSR requirements.
• Own internal document control, change control, design control, and risk management (ISO 14971).
• Drive root‑cause investigations, corrective and preventive actions (CAPAs) to resolve quality issues.
• Plan, schedule, and conduct internal QMS audits to ensure continuous compliance.
• Oversee product complaint handling, customer feedback tracking, and post‑market quality metrics.
• Collaborate with technical and regulatory teams to separate internal quality execution from external submission documentation.

Required profile

• 3‑5+ years of hands‑on Quality Assurance/QMS management experience in IVD or medical devices.
• Proven experience preparing for and managing MDSAP and ISO 13485/EU IVDR audits.
• Strong knowledge of ISO 13485:2016, ISO 14971, EU IVDR, and US FDA QSR.
• Ability to independently manage day‑to‑day QMS workloads, document control, and CAPAs.
• Lead Auditor certification for ISO 13485/MDSAP is desirable.

Required skills

• ISO 13485:2016
• ISO 14971 (risk management)
• EU IVDR
• US FDA QSR
• MDSAP
• Document control and change management
• CAPA management