About the Company:
Our client is a global manufacturer renowned for its products used in testing for multiple infectious diseases. Due to growth, their team is expanding and they are looking to hire a QARA Associate to join the team in Sydney. It is an exciting opportunity to support both functions and learn from an experienced head of QA/RA. Our client strives to create an inclusive culture in which difference is recognised and valued.
About the Role:
The role offers a unique opportunity to work for an IVD manufacturer/sponsor, with responsibilities in both quality and regulatory areas. The successful candidate will be involved in enhancing the quality management system and will also contribute to compiling dossiers and technical files for IVDR, WHO, and TGA submissions.
Key responsibilities for this role: - Compile data on QMS processes and participate in the generation of CAPAs, NCRs, Document Control and Complaint handling.
- Assist with technical writing and SOP preparation
- Support post-audit CAPA investigations with the R&D team
- Support regulatory file maintenance projects
- Research emerging regulatory/technical areas related to department projects.
- Create PowerPoint training presentations on MQS/new regulations.
- Build relationships with key stakeholders cross-functionally.
This is a fantastic opportunity for someone to utilize their quality and regulatory experience in the Diagnostics or Medical device industry. Ideally, you will have a medical science, biochemistry or biomedical engineering background and relevant QARA experience of 2-3 years in a manufacturing Australian sponsor setting. Additionally, you should be an enthusiastic, collaborative team player who is keen to learn.
About You: - Practical knowledge and understanding of ISO13485
- Proven technical writing skills
- Clear communication and interpersonal skills
- High Attention to detail
- Experience working with QMS and MS Office - word, PowerPoint, excel
- Team player with a 'Can do' attitude
Days in the office will be flexible however, you are required to work 3 days in the office.
How to Apply:
If this role sounds like you and you meet the above criteria, please click 'APPLY' now. We are short-listing candidates for this role and looking to appoint someone to commence ASAP.
KE Select is an Australian-based, leading Scientific & Medical Recruitment Partner for many organisations within the Life Science, Medical, Clinical, Hospital and Healthcare space. We specialise in Permanent and Temporary recruitment across Australia and New Zealand. If you are a candidate looking for a new role or a company looking for an industry-specific recruitment firm, please visit our website to find out more. www.keselect.com
