Cdd 6 Mois - Lyon, France - bioMérieux

bioMérieux

Entreprise vérifiée

Lyon, France

il y a 1 semaine

Posté par:

Sophie Dupont

beBee Recruiter

Description

A family-owned company, bioMérieux has grown to become
a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed
innovative diagnostics solutions to
improve public health.

Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Our Quality premarket department, look for a Quality R&D Engineer (F/M) for Immunoassays range who will evolve within the Quality R&D Immunoassay & Molecular team based in France.

What will be your responsabilities ?

Ensure and maintain the quality and conformity of products during Product Development Process, and during the Life Cycle.
Contribute to improve and harmonize Quality Practices
Reinforce interaction with other stakeholders to share the Quality best practices.

In this context, your tasks will be:

Serves as member of a Project team as the Quality, R&D representative.
Serve as the Quality Assurance representative for Immunoassays R&D project teams in regard to applicable regulations, standards and policies and supports the internal/customer/corporate audit process
Participates and supports the development of R&D Product Development and Lifecycle Management Activities across impacted sites for Immunoassays range.
Provide Quality R&D support for other Quality groups regarding lifecycle management including nonconformities/deviations, investigations, change controls and CAPA's related to products.
Participate in Field Action board when appropriate, and act as the Quality representative for the Anomaly Review Board.
Support the implementation of new regulations and participate in regulatory or standard watch
Ensure the maintenance of the Risk Management File of the products in your portfolio
Participate in the drafting of Post-Marketing Surveillance reports

You will also have more cross-functional missions to develop quality at the service of customers, by sharing best practices while respecting the specificities of the businesses and delivering tangible improvements.

Who are you ?

You have at least 5 years of experience as Quality Engineer in the Health Industry. You are adwarded of Master degree in a scientific discipline, or relevant Health Industry (IVD, MD, Biotech or Pharma) experience within R&D, Product Development, Design Controls, Technical support, QE/QA/QC or Regulatory Affairs required. Knowledge in biology, and specially in Immunology is preferred, but not required.
Endowed with very good interpersonal skills, you have a real sense of service. Pragmatic, you have analytical and synthesis skills that allow you to challenge and be proactive. Your sense of urgency allows you to prioritize your activities easily.
The Pre-Market Quality team is made up of employees based on different sites (EMA and US) for these reasons a command of English (written / oral) is necessary for this position.
Knowledge of the standards applicable to medical devices is essential (ISO 13485, 21CFR820, EN 62366, IEC 62304, ISO14971, 21CFR11, MDR 2017/746 and CLSI) is also a prerequisite.

The position will be based at the Marcy l'Etoile site, and travel to sites in the Lyon region (Marcy/La Balme) is to be expected.

(15 %)