Quality Manager

About the role

The Quality Manager will ensure that all products, services, and internal processes meet regulatory requirements, quality standards, and customer expectations. This role drives continuous improvement, maintains ISO certifications, and promotes a culture of quality excellence across the organisation.

Key responsibilities

• Monitor QMS performance, analyse data and recommend improvements.
• Establish, implement, maintain and continually improve the Quality Management System.
• Document processes following ALCOA+ principles and promote regulatory awareness.
• Lead internal and external audits, including ISO surveillance, supplier and customer inspections.
• Conduct cross‑functional risk assessments and ensure product quality risks are mitigated (ALARP).
• Oversee supplier qualification and ongoing quality control for raw materials and outsourced services.

Required profile

• Bachelor's degree in science, engineering or related field.
• Certified Lead Auditor for ISO 9001 or ISO 13485, or equivalent qualifications.
• Proven experience managing QMS in a regulated industry, preferably medical device or food manufacturing.

Required skills

• In‑depth knowledge of ISO 9001, ISO 13485, GMP and Australian regulatory requirements.
• Understanding of ISO 14971 or ISO 31000 risk management standards.
• Experience with root cause analysis, CAPA implementation and audit management.
• Lean Manufacturing or Lean Six Sigma methodology.