- 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 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 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 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, robust attention to detail and individuals who can provide practical quality guidance while maintaining high regulatory standards.

How to Apply
Ready to take the next step? Click apply or contact Gemma Staddon on [email protected] for a confidential discussion.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

- Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;

- Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
- Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D;, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
- Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

📌 Quality Engineer (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney