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Form of workFull time permanent position based in Sydney Working on a device with cutting-edge technology that assists with surgeries! Be involved and part of an exciting international product launch!
Our client, an innovative MedTech company is looking for a Quality Lead Engineer to oversees production, product release and the internalisation of manufacturing processes. This role is integral to uphold the high-quality standards of their cutting-edge product. Reporting to the Quality Manager, you will be assisting the project of setting up the new manufacturing site, qualifying suppliers and registering complaints to ensure compliance with applicable regulatory standards.
Your other responsibilities will also include, but not be limited to: Managing supplier facilities and documentations Participating in risk management and gap assessment activities Engaging in post-market surveillance activities Managing customer complaints, NC reports, root cause analysis and CAPA etc. This is a great opportunity for an experienced Quality Engineer to join a collaborative team with great culture to be part of an innovative product launch for surgeons which incorporates with smart technology! To be considered for this role, you will have the following skills and experience: Bachelor of Engineering 2 to 3 years of experience in a manufacturing setting of medical devices Strong experience in Quality Engineering with strong emphasis on manufacturing processes, setting up and qualifying manufacturing sites.
Sound knowledge and experience in ISO 13485 Excellent communication skills (both written and verbal) High level of internal and external stakeholder interaction skills Previous experience or knowledge in GMP would be highly regarded If this sounds like…
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