Dreem is focused in maintaining a high level of regulatory compliance for its products & processes. The next year will be full of challenges for the RAQA team, including audit certification processes & new products on the market. This is why Dreem is looking for a Quality Assurance Specialist that is willing to support the improvement of Dreem Quality System. You will work in close collaboration with Hardware, Software & Industrialization Team, & you will have a critical role for ensuring that products & processes meet regulatory requirements.
For this role we need a person with outstanding ability to prioritize & organize tasks, manage workload efficiently & capacity to work well in teams. You will be involved in critical activities such as audit preparation & drafting of documentation for notified bodies & competent authorities.
Dreem Quality team has been focused in the last year in the development of a quality management system that allowed the company to distribute its first medical device in United States. In this context, the goal for the future is to strengthen the quality system in order to obtain & maintain ISO 13485 certification & keep a high level of compliance to regulatory standards.
- Execution of QMS related activities: update procedures & working instructions, management of CAPA, Non-conformity & Training.
- Updating of technical documentation in compliance with international Medical Device Regulation.
- Review of customer complaints & preparation of report for competent authorities,when necessary.
- Preparation of technical documentation for validation activities & execution of the related validation/verification tests.
- Preparation of internal, external & supplier audits;
- Continuously improving the Quality Management System by keeping documentation up to date & ensure integrity of QMS documents;