Health and Aged Care Professionals – Sydney NSWFull time1d ago , from Health and Aged Care ProfessionalsBenefitsPermanent full-time opportunity within a global med-tech companyWork across innovative medical devices and SaMDExposure to global quality systems, regulatory requirements and cross-functional projectsAbout the companyJoin a global medical technology organisation focused on developing cutting-edge 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 opportunityAn 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.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 projectsPartner 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 discipline2 + years in Quality Assurance within the medical device industryWorking knowledge of ISO ***** and medical device quality systemsExperience working with SaMD would be an advantageStrong technical writing and controlled documentation experienceExposure to design controls and product or software lifecycle processesStrong analytical and problem‐solving skillsCollaborative approach with the ability to work across multiple business functionsCultureJoin a collaborative and quality‐focused environment where teams work closely across Quality, Regulatory, Engineering and Operations.
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📌 Qa Engineernew (New South Wales)
🏢 Health and Aged Care Professionals
📍 New South Wales