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.

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).

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.

Key Responsibilities

- Support compliance with ISO 13485, ISO 14971, TGA, EU MDR and internal QMS requirements.
- Support internal, external and regulatory audits, including preparation, documentation and follow-up actions.
- Assist with the investigation and documentation of complaints, non-conformances, CAPAs and risk assessments.
- Maintain controlled documents and quality records in accordance with QMS requirements.
- Contribute to post-market surveillance and ongoing product quality activities.




- Partner with Regulatory Affairs, Engineering, Sales, Operations, Marketing and other functions to provide practical QA guidance.

To be considered for this role, you should have:

- Bachelor’s degree in Engineering, Science or a related field.
- 2+ years’ experience in Quality Assurance or a related function within the medical device industry.
- Working knowledge of ISO 13485 and quality management systems.
- Experience with software as a medical device (SaMD).
- Experience with eQMS platforms and Microsoft Office.
- Strong analytical and problem-solving skills.
- Experience supporting audits within a regulated environment.

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 rapid paced, growing, innovative global organisation.

To apply for this role please submit your application in WORD format by clicking 'Apply'; or contact Krista Midri on 0447 273 551 for a confidential discussion. Confidentiality is assured.

📌 Quality Assurance Engineer | Medical Devices | Sydney
🏢 Heng u0026amp; Hurst
📍 Sydney