ESTABLISHING A QUALITY MANAGEMENT SYSTEM FOLLOWING THE ISO 13485: 2016 REFERENCE IN AN IN VITRO DIAGNOSTIC START-UP
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LumediX is a young company created in 2018, and a spin-off of the Ecole Polytechnique. The technology it has developed is based on rare-earth luminescent nanoparticles that amplify the sensitivity of in vitro diagnostic tests by several orders of magnitude. This opens new horizons for performing better tests that are easier to implement and improve the lives of patients.
Main objectives of the internship:
The main objectives of the internship are:
- Continue the implementation of an ISO 13485:2016 quality standard
- Implementation of a technical file for a future CE-IVD marking
- Develop a culture awareness for quality management within the company
In close collaboration with the entire LumediX team and with a firm specialized in the field:
- Identify processes adapted to the current size of society while anticipating its development.
- Contribute to the overall definition of LumediX’s quality policy.
- Write the general processes and procedures of the Quality Management System.
- Establish performance indicators for each identified process.
- Build Risk Analysis of the company’s product line.
- Design solutions to optimize the quality of the production process.
- Establish a system for monitoring regulations and standards related to LumediX’s activities (in particular the use of nanoparticles).
- Raise awareness among all LumediX employees for issues related to the Quality Management System and involve them in its implementation.
This internship can lead to a hiring on permanent contract.
6 months (minimum of 4 months)
Campus Ecole Polytechnique (Palaiseau) or Paris
- Training: Master 2 profile with a specialty in Quality / Regulation
- Personal qualities: team spirit, rigor, sense of organization. Willingness to work in a “start-up” environment, with the possibility of participating in the development of breakthrough products in an upstream phase.
- Fluent English (written and oral)
firstname.lastname@example.org citing reference HR-ST-001