Senior Quality Systems Manager

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

Introduction: At Nanosonics, our mission is to improve the safety of patients, clinics, their staff and the environment by transforming the way infection prevention practices are understood and conducted. As a global leader in automated infection prevention solutions for medical device reprocessing, we are continuing to scale our quality systems to support innovation, compliance and growth across international markets.

About The Role

We are seeking a Senior Quality Systems Manager to provide enterprise-level leadership and ownership of our global, multi-site Quality Management System. Reporting to the Head of Global Quality and Technical Services, this senior role is accountable for the design, governance, lifecycle management, harmonisation, simplification and sustained regulatory compliance of the QMS across manufacturing sites, regions and countries.

This is a highly visible leadership role for an experienced quality systems professional who can balance regulatory compliance, operational effectiveness and business scalability. You will act as a trusted advisor to senior leaders, shape quality system capability for future growth, and lead a capable team of quality professionals.

What you will do

• Own and govern the global QMS across all sites, ensuring sustained compliance with ISO 13485, FDA 21 CFR 820, MDSAP and EU MDR requirements.
• Establish enterprise-level standards, policies and processes that enable global consistency while supporting appropriate regional flexibility.
• Lead QMS uplift initiatives focused on harmonisation, simplification, scalability, digital enablement and risk-based design.
• 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, building capability through coaching, training frameworks and succession planning.
• Oversee key QMS processes including document and records management, change control, audits, CAPA, QMS competency development and training.
• Represent the QMS in internal and external forums, including certification audits, QMS reviews, regulatory interactions and stakeholder engagements.

About you

You are an experienced quality systems leader with an enterprise mindset, strong stakeholder influence and a disciplined approach to compliance, continuous improvement and people leadership. You are comfortable operating across geographic boundaries and time zones, and you bring the confidence to guide senior decision-making on quality risk, regulatory exposure and system trade-offs.

What you will bring

• 10+ years’ experience in quality systems, quality management, regulatory affairs or a related discipline within medical devices, life sciences or another highly regulated environment.
• Strong practical knowledge of ISO 13485, FDA 21 CFR 820, MDSAP, EU MDR and GMP requirements.
• Experience leading QMS governance, audits, CAPA, change control, document control and continuous improvement programs.
• Demonstrated ability to lead experienced quality professionals and build high-performing, engaged teams.
• Tertiary qualifications in Engineering, Science or a related discipline.
• Strong communication, stakeholder engagement, project management and influencing skills.
• Working knowledge of QMS, document control, ERP and related business systems; experience with Objective or similar systems is advantageous.

Why join Nanosonics?

You will join an Australian-founded global medical technology company with a clear purpose: improving standards of care through infection prevention innovation. This role offers the opportunity to shape enterprise quality systems at scale, influence senior leaders, support global growth and contribute to technologies that help protect patients and healthcare professionals.

Our core values — Collaboration, Innovation, Discipline, Agility and Will to Win — guide how we work together and how we deliver on our commitments.