Cette offre est lié au département Quality
1. About Dreem
Each and every night, around the world, hundreds of millions of people are trying to sleep but can’t(e)We’re in the middle of a global sleep crisis with serious ramifications for society(e)At Dreem, a team of 50 experts is on a mission to beat insomnia, build new ways to analyse the sleep and build the sleep medicine of tomorrow.
In the 7 years since Dreem’s creation, we’ve collected 2M nights of sleep data and helped thousands of people improve their sleep(e)We also accumulated 45 patents and completed 3 full hardware iterations and 100s of software iterations(e)We raised $60M from investors including Laurent Alexandre, Xavier Niel, MAIF, BPI and Johnson & Johnson - the world’s healthcare leader(e)Along the way we created a research network of 200 leading laboratories and hospitals and a scientific board of 4 of the most renowned neuroscientists and sleep experts in the world.
Dreem is a fast-paced and dynamic work environment(e)The team’s fields of expertise encompass sleep research, neuroscience, mechanical engineering, machine learning, electronic design, embedded systems, testing, ergonomics, development of proprietary applications and software, design, marketing and much more(e)Joining the team is challenging but hugely rewarding- working at Dreem means pushing the boundaries and being able to bring real positive change to people around the world(e)Ready to join the fight for better sleep?
2. About the role - Importance of the role (a.k.a(e)this is why we need you)
Today our missions with top pharmaceutical companies and prestigious research centers are growing rapidly and we are looking for a Quality Assurance Engineer or Pharmacist to join and contribute to this scale up.
Job description
We are seeking a highly motivated Quality Assurance Engineer or Pharmacist who will work to keep Dreem Quality Management System compliant with all the applicable regulations and standards(e)This newly created role will report to the Quality Manager and work in collaboration with all departments (Clinical, Regulatory, Hardware, Software, Analytics, etc.).
Key missions
- Maintenance of a robust and fully compliant Quality Management System in accordance with ISO 13485 and 21 CFR 820;
- Act as Management Representative Deputy in absence of the Quality Manager;
- Management of CAPA, NC, complaints, CC, regulatory watch;
- Preparation of quality documentation including procedures, records, templates;
- Management of KPI/data analysis, support in Management review activities;
- Management of audits (internal audits, 2nd-party audits and 3rd-party audits);
- Support software validation activities, in collaboration with a dedicated team, in accordance with FDA guidelines, GAMP-5 methodology and in alignment with all the other applicable regulations (21 CFR part 11, EU Annex 11);
- Management of quality training to employees;
- Support quality-related activities for the manufacturing process, in collaboration with the contract manufacturer and critical suppliers;
- Support activities related to product verification and validation, including risk management, biocompatibility testing (ISO 10993), usability studies, performance and reliability tests.
About you - Requested qualifications & experiences
- 1-5 years of experience in Quality Assurance, for medical device organizations ideally;
- Knowledge of ISO 13485 and 21 CFR 820;
- Ability to work in a fast-paced, startup environment;
- Good project management skills, ability to meet deadlines and manage multiple activities at the same time;
- Communication and negotiation skills;
- Easy-going: positive attitude, resourceful and team-spirit;
- Fluent English (oral and written communication).
About you - Preferred qualifications and experience
- Experience in digital medical devices;
- Experience in 2nd-party and 3rd-party audits, interaction with Notified Bodies;
- Knowledge of GCP requirements and software validation techniques (GAMP-5, 21 CFR part 11, EU Annex 11);
- Knowledge in risk management (ISO 14971, ISO 24971);
- Knowledge of medical device technical standards such as ISO 10993, IEC 60601 family of standards, IEC 62366, ISO 15223, post-market surveillance standards (ISO 20416).
Additional Information
- 🏡 Great office in the center of Paris (75003)
- 🍽 Swile (Tickets Restaurants)
- 🏃♂️ Gymlib 🚈
- 50% pass Navigo or bike indemnities