A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Our Clinical R&D Quality Department is looking for a permanent R&D Quality Engineer (F/M) who will work in the microbio-automated R&D Quality team in a team of 4 employees.
What will be your responsibilities at bioMérieux?
Our Quality premarket department, look for a Quality R&D Engineer Sys/SW (F/M) who will evolve within the Microbio- automatized Quality R&D team based in France and the US.
- Ensure and maintain the quality and conformity of products on the field
- 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 :
- Ensure product compliance after marketing (DHF, RMF, Design Change, etc.)
- Ensure the follow-up of Investigations following field feedback
- Participate in CAPA follow-ups
- Participate in the follow-up of the most critical subjects, and in the decision-making of the actions that will result from it (FCA, FSCA, etc.)
- Ensure the maintenance of the Risk Management File of the products in your portfolio
- Participate in the drafting of Post-Marketing Surveillance reports
- Support the teams in the preparation of audits and be the privileged referent at the QA level on the products of your portfolio which will be mainly Softwares.
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?
- 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.
- You have at least 5 years of experience in Quality Engineer and/or System Engineer positions in the Health Industry. 1-3 years’ experience in microbiology is preferred, but not required. You have been confronted during your various experiences with issues concerning complex systems and/or “System of System” subjects.
- 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 and MDR 2017/746) is also a prerequisite.
- The position will be based at the La Balme les Grottes site, and travel to sites in the Lyon region (Marcy/Grenoble/Craponne) is to be expected. (15 to 50%)
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.