Global QMS Leader – Medical Devices & Compliance

Nanosonics; Sydney; On-site; AUD 180,000 - 240,000; Full time

Job summary

Nanosonics, an Australian-founded global medical technology company, seeks a Senior Quality Systems Manager to lead the global QMS across sites. You will own governance, lifecycle management and regulatory compliance, supporting growth and scaling across international markets.

This senior role requires balancing compliance with operational effectiveness, and you will lead a team of quality professionals while shaping QMS capability for future expansion.

Qualifications

• 10+ years’ experience in quality systems or regulatory affairs within medical devices or regulated environments.
• Strong knowledge of ISO 13485, FDA 21 CFR 820, MDSAP, EU MDR and GMP requirements.
• Experience leading QMS governance, audits, CAPA, change control and document control.

Responsibilities

• Own and govern the global QMS across sites, ensuring ongoing compliance with major standards.
• Establish enterprise-level standards and processes for global consistency with regional flexibility.
• Lead QMS uplift initiatives focused on harmonisation, simplification, scalability and digital enablement.
• Partner with manufacturing, operations, R&D, commercial, regions and country teams to balance speed, innovation and compliance.
• Lead and mentor a global Quality Systems team and drive training and succession planning.
• Oversee QMS processes including document management, change control, audits, CAPA and training.
• Represent QMS in audits, regulatory interactions and stakeholder engagements.

Skills

Quality systems leadership

ISO 13485

Regulatory compliance

QMS governance

Stakeholder management

Leadership

Education

Engineering/Science degree

Tools

ERP

QMS software

Document control systems

Job description

Nanosonics, an Australian-founded global medical technology company, seeks a Senior Quality Systems Manager to lead the global QMS across sites. You will own governance, lifecycle management and regulatory compliance, supporting growth and scaling across international markets.

This senior role requires balancing compliance with operational effectiveness, and you will lead a team of quality professionals while shaping QMS capability for future expansion.