Presentation of the company and the sector of activity :
ENDODIAG, an innovative and fast growing SME based in Paris (75014) is specialized in the development of diagnostic tests, monitoring and prognosis of endometriosis in order to improve the management of patients. Endometriosis affects 10% of women of reproductive age and causes various disorders (pain, bleeding, infertility, fatigue ...).
Mains responsabilities :
Attached (e) to the direction, you will join the team AQ / Regulation / Clinic of the company. You will be in charge of setting up and managing Endodiag's Quality Management System in accordance with ISO 13485. You will apply internal national and international standards relating to our activities. You will actively participate in the compliance procedures required for the EU and US marketing of our products.
Your duties :
- Implementation of the Quality Management System according to ISO13485: 2016;
- Evaluate the system using Quality indicators, internal audits and animate the process of continuous improvement, notably by conducting management reviews;
- Be an active facilitator of internal quality assurance and raise staff awareness of good laboratory practices and other associated guidelines;
Required profile :
-Engineering degree or equivalent level Bac + 5 scientist (ideally in medical devices DM and DMDIV), with specialization quality assurance and regulation of health products (DM, DIV, biotechnologies);
- Deep knowledge of quality referentials for medical devices for in vitro diagnostics and biotechnology / laboratory (New European Regulation DM / DMDIV, ISO 13485, Directives 98/79 / EEC and 93/42 / CEE, ISO 17025 /)
- Similar experience of 2 years minimum
- Written and spoken English (justified by experience abroad and / or score on a recognized test)
Required skills and abilities :
- Rigorous and analytical skills,
- Ability to work collaboratively and team spirit,
- Communication skills
Remuneration: depending on the profile
Start date: as soon as possible
How to apply: Send CV + cover letter by mail to contact@endodiag.