Health and Aged Care Professionals – Sydney NSW

Contract

20h ago , from Health and Aged Care Professionals

- 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

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 setting

About the company

Join a global medical technology organisation focused on developing innovative solutions that improve patient outcomes.

About the chance

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 13485, ISO 14971 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 activitiesMaintain 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 13485 and medical device quality systems
- Strong 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, strong attention to detail and individuals who can provide practical quality guidance while maintaining high regulatory standards.

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📌 Quality EngineerNew (New South Wales)
🏢 Health and Aged Care Professionals
📍 New South Wales