Perks
Permanent full-time opportunity within a global med-tech company
Work across innovative medical devices and SaMD
Exposure to global quality systems, regulatory requirements and cross-functional projects
About the company
Join a global medical technology organisation focused on developing innovative solutions that improve patient outcomes.
With an established international presence, the business operates within highly regulated healthcare environments and continues to invest in technology, quality and product development.
About the opportunity
An exciting opportunity is available for a QA Engineer to join this growing team here in Sydney.
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 position 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.
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
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
2 + years in Quality Assurance within the medical device industry
Working knowledge of ISO ***** and medical device quality systems
Experience working with SaMD would be an advantage
Strong technical writing and controlled documentation experience
Exposure to design controls and product or software lifecycle processes
Strong analytical and problem-solving skills
Collaborative approach with the ability to work across multiple business functions
Culture
Join a collaborative and quality-focused environment where teams work closely across Quality, Regulatory, Engineering and Operations.
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📌 Qa Engineer (New South Wales)
🏢 Healthcare Professionals Group
📍 New South Wales