The main mission of the role involves supporting the team during the set-up of the companys Quality Management System, in compliance with the main medical device regulations such as ISO 13485:2016 & FDA Quality System Regulation.
This consists of:
- Preparation of Quality Management System documentation: Procedures, Working Instructions & Modules.
- Support in the definition of the companys internal processes (such as supplier management, training, change control) & the preparation of related documentation.
- Management of key quality processes such as Customer Complaints, Validation actives & CAPA.
- Ensuring that electronic documents are managed according to the internal process & applicable regulatory standards.