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Forme de travailA 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.
The bioMérieux Industrial Applications Quality Assurance department aims to enable the company business growth with customer centricity, while managing risks and regulatory compliance through adjusted quality processes and support to global functions.
The department is made up of three divisions: the Quality Management Support division, the Registration & Customer Quality Compliance division, and the Pre & Post Market Quality division.
It is within the Pre & Post Market Quality division that we are looking for a Quality Engineer who will be fully involved in managing our product development as well as their lifecycle.
You will report directly to the Industrial Applications Pre & Post Market Quality Manager, who is based in Philadelphia and English-speaking. As part of a team of 7 people (14 in total in the Industrial Quality department) and based in Craponne, your main missions will be:
Monitor a product portfolio intended to food and/or pharmaceutical industrial diagnostic (reagents, instruments, software; microbiology, molecular biology, immunology); as such, you will be:
Member of the project teams for developing or modifying these products;
The preferred contact on your product portfolio and the guarantor of the quality processes implemented throughout the product lifecycle (such as design control, design change management, field actions management), in accordance with bioMérieux, international and customer requirements.
Pilot and ensure that product risk management is controlled all along the product lifecycle.
Be able to challenge and to propose alternatives on technical and strategic choices and decisions made in the projects, with regards to risk-taking on quality and business aspects; be able to escalate wisely.
Ensure a role of quality referent on your ranges:
advise the R&D teams on design controls; with regards to your development skills, you will be able to contribute to mentoring other métiers on the design control and product risk management topics;
manage the organization of Field Action Board meeting in charge of deciding on the actions to be taken in the field in the event of problems with the marketed products; as such, you will interface with GiCS (global industry customer service) representatives, manufacturing site quality managers and program directors, in addition to the Quality Director of the Industrial Applications Unit (N+2).
Be the preferred contact for other functions, on the axis of the quality serving the business for your ranges.
Support the teams for audit preparation and be the auditor preferred contact for quality purposes about development and field actions on your product portfolio.
Contribute to improving the product lifecycle efficiency or any quality process required within the Unit; as such, you will coordinate or contribute to continuous improvement initiatives as well for your ranges as for overall practices harmonization, interfacing with other professions.
Who are you?
- Graduated with a minimum of French BAC + 5 years, you ideally have an engineering degree in biology, biomedical, instrumentation, software or equivalent.
- You have at least 4 years of experience in a quality family job, in the medical or food field (medical devices, in vitro diagnostic, pharmaceutical industry, food industry); experience in design control for the development of reagents and/or instruments is a bonus.
- You know the standards applicable to design control and to pharma and/or food field (ISO 9001, ISO 13485, ISO 14971, 21CFR820, GAMP, 21CFR11, GMPs, ISO 16140 …) and you have the capacity to act as if you were a quality auditor.
- You know how to work in project mode and have good knowledge of quality management systems.
- You have good interpersonal skills, and a real sense of service.
- You have analytical and synthesis skills allowing you to challenge wisely, and you are pragmatic and proactive.
- Fluent in English is essential (written, oral) with B2 level as a minimum (English-speaking direct manager).
- Knowledge of the industrial domain is strongly expected (pharmaceutical, cosmetic, food industries)
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.
