QA Engineer

Benefits

• 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 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
• 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 13485 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.