Job Description
We are partnering with a global medical technology organisation delivering innovative solutions across orthopaedic devices, surgical technologies and digital health. This is an opportunity for a Quality Assurance Engineer to join the Sydney-based QA team.
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Working as part of a global QA function, you will support manufacturing quality, post-market surveillance, complaint handling, audits, CAPA and risk management, while also gaining exposure to design controls and software as a medical device (SaMD).
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You will work closely with Engineering, Regulatory Affairs, Operations, Sales and Marketing, providing practical quality guidance and helping ensure quality requirements are embedded throughout the product lifecycle.
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Key Responsibilities
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Support compliance with ISO *****, ISO *****, TGA, EU MDR and internal QMS requirements.
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Support internal, external and regulatory audits, including preparation, documentation and follow-up actions.
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Assist with the investigation and documentation of complaints, non-conformances, CAPAs and risk assessments.
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Maintain controlled documents and quality records in accordance with QMS requirements.




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Contribute to post-market surveillance and ongoing product quality activities.
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Partner with Regulatory Affairs, Engineering, Sales, Operations, Marketing and other functions to provide practical QA guidance.
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To be considered for this role, you should have:
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Bachelor's degree in Engineering, Science or a related field.
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2+ years' experience in Quality Assurance or a related function within the medical device industry.
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Working knowledge of ISO ***** and quality management systems.
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Experience with software as a medical device (SaMD).
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Experience with eQMS platforms and Microsoft Office.
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Robust analytical and problem-solving skills.
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Experience supporting audits within a regulated environment.
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If you enjoy solving problems, improving processes and working cross-functionally, this role gives you the scope to build your medical device QA experience while working within a fast paced, growing, innovative global organisation.
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📌 Quality Assurance Engineer | Medical Devices | Sydney (New South Wales)
🏢 Heng & Hurst
📍 New South Wales