Quality Manager

Paris /
Regulatory /
Full-time
About Dreem:
Each and every night, around the world, hundreds of millions of people are trying to sleep but can’t. We’re in the middle of a global sleep crisis with serious ramifications for society. At Dreem, a team of 50 experts is on a mission to beat insomnia 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.  We also accumulated 25 patents and completed 4 full hardware iterations and 100s of software iterations.  We raised $60M from investors including Laurent Alexandre, Xavier Niel, MAIF, BPI and Johnson & Johnson - the world’s healthcare leader. Along the way we created a research network of 250 leading laboratories and hospitals and a scientific board with some of the most renowned neuroscientists and sleep experts in the world. 
Dreem is a fast-paced and dynamic work environment. 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, and much more. 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. Ready to join the fight for better sleep? 

Job Description

We are seeking for a highly motivated Quality Assurance Manager that will lead our Dreem Quality Management System.  You will work to keep Dreem's quality system compliant with all the applicable regulations, in collaboration with the Clinical & Regulatory Team, HW and SW development team.

Responsibilities (include but are not limited to):

    • Maintenance of a robust and fully compliant Quality System in accordance with ISO 13485:2016 and 21 CFR 820;
    • Act as management representative and be responsible for QMS related KPI/data analysis, leading management review;
    • Manage Quality System audit processes, including 2nd party and 3rd party audits;
    • Act as a reference point within the organization for all the quality-related topics;
    • Oversee 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 the delivery of trainings to company employees; 
    • Manage Quality related activities for device manufacturing process, in close collaboration with the contract manufacturer and critical suppliers;
    • Support activities related to product verification and validation, including risk management, biocompatibility testing (ISO 10993), usability study, performance and reliability tests;  
    • Management of CAPA, NC, customer complaints and related reportability evaluation;
    • Ensure activities are conducted in compliance with the regulations and standards applicable to the product.

Essential Qualifications and Experience:

    • 5 years of experience in Quality Assurance for medical device organizations; 
    • In depth knowledge of ISO 13485:2016, 21 CFR 820 and risk management (ISO 14971, ISO 24971); 
    • Experience in the management of 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 of medical device technical standards such as ISO 10993, IEC 60601 family of standards, IEC 62366, ISO 15223, post-market surveillance standards (ISO 20416); 
    • Very good project management skills, ability to meet deadlines and manage multiple activities at the same time;  
    • Strong analysis and problem-solving skills;
    • Communication , negotiation skills and fast decision making.

Preferred Qualifications and Experience:

    • Experience in digital medical devices and related FDA regulations;
    • Knowledge of information security management system (ISO 27001) and FDA cybersecurity requirements.
Benefits:
- Startup environnement with a young, passionate, smart team.
- Good healthcare provider with “Alan”
- Luncheon vouchers
- Gymlib passes
- BSPCE participation (for full-time contracts)
- Flexible hours
- Remote working (up to 60% a week)
- Great office in a central location in Paris
- Regular events and parties (breakfast, monthly party, team building, annual summer summit trip...) when the conditions get better
- And of course… your very own Dreem headband.