Quality Engineer - Global Industrial Applications

BioMerieux · Craponne

A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

Our Industrial Microbiology Unit brings together more than 900 employees around the world. Our mission is to provide the agri-food, pharmaceutical and cosmetic industries with microbiology control solutions to improve product safety and quality.

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

We are looking for a Quality Engineer who will work and grow within the Global Industrial Applications - Pre and Post Market Quality department/unit and will report to Director of Global Quality within a team of 5 co-workers.

What will be your mission within bioMérieux ?

Monitor the product portfolio intended for Industrial diagnostics - Pharma Quality, and Food Safety and Quality - (molecular biology and microbiology reagents, instrument, software); as such, you will be:
- Member of the project teams for developing or modifying these products.
- The preferred contact 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 bioMerieux, 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.
Manage the organization of Field Action Board meetings 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 manager, program directors and Industrial Applications Quality Managers.
Be the preferred contact for other functions, on quality processes for your product ranges.
Support the teams for audit preparation and be the preferred audit 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 Industry 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?

Bachelor’s Degree, Master’s preferred, with > 4 years of industry experience or equivalent experience in related industry. Experience in quality job and design control for the development of reagents and/or instruments is preferred.
Expertise in molecular biology, microbiology techniques and diagnostic product development.
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.
Knowledge of the industrial domain is strongly expected (pharmaceutical, cosmetic, food industries) Experience in participation in the management of regulatory audits (i.e. ISO 9001, ISO 13485, FDA, etc.).
Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, AFNOR etc.)
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.

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.

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