Benefits6-month contract opportunity with a global medical device companyWork across creative medical devices/SaMDExposure to global quality systems, regulatory requirements and cross-functional projectsGreat culture and flexible working environmentAbout the companyJoin a global medical technology organisation focused on developing innovative solutions that improve patient outcomes.About the opportunityWorking 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.DutiesSupport compliance with ISO *****, ISO ***** and internal Quality Management System requirementsAssist with internal, external and TGA audits and inspectionsSupport investigation and documentation of complaints,



non-conformances and CAPAsAssist with risk assessments and ongoing quality improvement activitiesMaintain controlled documents and quality records within the QMSSupport quality and compliance training across the organisationAssist with Design Controls activities supporting new product development projectsEvaluate non-conforming materials and support disposition decisionsPartner with Engineering, Regulatory Affairs, Operations, Sales and Marketing teamsParticipate in cross-functional projects to ensure quality and regulatory requirements are metSupport alignment between Australian quality activities and global policies and proceduresSkills and ExperienceBachelor's degree in Engineering, Science or a related disciplineMinimum 2 years' Quality Assurance experience within the medical device industryWorking knowledge of ISO ***** and medical device quality systemsStrong technical writing and controlled documentation experienceExposure to design controls and product or software lifecycle processesExperience supporting regulatory audits, including TGA, FDA or international audits, advantageousStrong analytical and problem-solving skillsCollaborative approach with the ability to work across multiple business functionsFull working rights for the duration of the 6-month contractCultureJoin 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 Engineer (New South Wales)
🏢 Healthcare Professionals Group
📍 New South Wales