Global Head of Quality & Regulatory

Multigate Medical Products; Sydney; On-site; AUD 180,000 - 260,000; Full time

Benefits offered by this job

Free onsite parking

Gym membership

Close to public transport

Job summary

Multigate Medical Products, a leading Australian medical devices manufacturer, seeks a Head of Quality to steer quality, regulatory, and compliance across national and international operations. You will shape the quality strategy, manage QA/QC, complaints, CAPAs, and audits, and drive post-market activities to enable growth.

You will lead scalable QMS, ensure TGA and ISO 13485 alignment, and partner with leadership on expansion, transformation, and mergers.

Qualifications

• Senior quality leadership experience in medical devices or regulated manufacturing.
• Experience establishing quality strategies with measurable outcomes.
• Experience managing integrated quality systems across multiple sites and international operations.
• Proven track record in supporting international market expansion and growth initiatives.
• Strong knowledge of regulatory frameworks and quality standards.

Responsibilities

• Provide strategic leadership to ensure ongoing compliance with regulatory standards (e.g., TGA, ISO 13485).
• Oversee an integrated quality management system across national and international operations.
• Govern complaints, non-conformances, CAPAs, risk management and post-market activities.
• Lead internal, external, supplier, and regulatory audits.
• Oversee validation activities and global quality operations to support growth.

Skills

Quality leadership

Regulatory compliance

Quality systems

Audits

Strategic thinking

Education

Science degree

Biomedical Science

Biomedical Engineering

Medical Technology

Microbiology

Tools

QMS software

Regulatory databases

Job description

Multigate Medical Products, a leading Australian medical devices manufacturer, seeks a Head of Quality to steer quality, regulatory, and compliance across national and international operations. You will shape the quality strategy, manage QA/QC, complaints, CAPAs, and audits, and drive post-market activities to enable growth.

You will lead scalable QMS, ensure TGA and ISO 13485 alignment, and partner with leadership on expansion, transformation, and mergers.