Benefits
6-month contract opportunity with a global medical device company
Work across innovative medical devices/SaMD
Exposure to global quality systems, regulatory requirements and cross-functional projects
Great culture and flexible working environment
About the company
Join a global medical technology organisation focused on developing innovative solutions that improve patient outcomes.
About the opportunity
Working as part of a global Quality Assurance function, you will support quality and compliance activities across medical devices, with a particular focus on SaMD.
This is a varied QA role covering quality systems, complaint handling, CAPA, non-conformances, audits, risk management and design controls. You will work closely with Regulatory Affairs, Engineering, Operations, Sales and Marketing to ensure quality requirements are embedded throughout the product lifecycle.
We are also open to speaking with candidates on a Working Holiday Visa who have relevant medical device QA experience and appropriate working rights for the duration of the contract.
Duties
Support compliance with ISO *****, ISO ***** and internal Quality Management System requirements
Assist with internal, external and TGA audits and inspections
Support investigation and documentation of complaints, non-conformances and CAPAs
Assist with risk assessments and ongoing quality improvement activities
Maintain controlled documents and quality records within the QMS




Support quality and compliance training across the organisation
Assist with Design Controls activities supporting new product development projects
Evaluate non-conforming materials and support disposition decisions
Partner with Engineering, Regulatory Affairs, Operations, Sales and Marketing teams
Participate in cross-functional projects to ensure quality and regulatory requirements are met
Support alignment between Australian quality activities and global policies and procedures
Skills and Experience
Bachelor's degree in Engineering, Science or a related discipline
Minimum 2 years' Quality Assurance experience within the medical device industry
Working knowledge of ISO ***** and medical device quality systems
Solid technical writing and controlled documentation experience
Exposure to design controls and product or software lifecycle processes
Experience supporting regulatory audits, including TGA, FDA or international audits, advantageous
Strong analytical and problem-solving skills
Collaborative approach with the ability to work across multiple business functions
Full working rights for the duration of the 6-month contract
Culture
Join a collaborative and quality-focused environment where teams work closely across Quality, Regulatory, Engineering and Operations. The organisation values continuous improvement, solid attention to detail and individuals who can provide practical quality guidance while maintaining high regulatory standards.
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📌 Quality Engineer (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney