QA Engineer intern

The Dreem Story

In 2014, two engineering students from the École Polytechnique made a discovery. Non-invasive brain stimulations, triggered at specific moments, can enhance the quality of deep sleep. With sleep being one of the biggest healthcare and societal issue of modern times, and sleep problems being poorly covered by existing solutions, they decided to start Dreem. Their mission? Solve the global sleep crisis by developing the first ever reference solution to bad sleep. A solution that is non-invasive, efficient and complete enough to cover every case. Dreem also has a scientific and technical goal- understanding sleep and the brain, in order to develop solutions that can significantly and positively improve our health, well-being and performances.

What’s this role about ?

The main mission of the role involves supporting the team during the set-up of the company’s Quality Management System, in compliance with the main medical device regulations such as ISO 13485:2016 and FDA Quality System Regulation.

This consists of:

• Preparation of Quality Management System documentation: Procedures, Working Instructions and Modules.
• Support in the definition of the company’s internal processes (such as supplier management, training, change control) and the preparation of related documentation.
• Management of key quality processes such as Customer Complaints, Validation actives and CAPA.
• Ensuring that electronic documents are managed according to the internal process and applicable regulatory standards.

Profile needed

• Bac +4 / 5 in a scientific or quality-related subject
• Strong interest in the medical device field
• Highly organized, proactive and willing to learn
• Excellent English written skills
• Hard worker.

Extras :

Basic knowledge of the main international regulations for Medical Devices: 21 CFR 820, ISO 13485 and European Medical Device Regulation (EU MDR).
Experience in medical device software.

Please Apply here.