Location: Marcy l'Etoile, France
Position Type: Unfixed Term
Job Function: Quality
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.
In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
The Global Product Risk Management Expert reports operationally to the Director, Global Quality, Product Development and Lifecycle Management. The role supports the Global Quality department to ensure adherence to Quality System regulatory requirements and applicable standards (e.g., ISO 14971, 13485, 9001 ).
Strong interpersonal and communication skills, and quality experience is required to closely partner with stakeholders within bioMerieux to drive continuous improvement initiatives specifically related to Product Risk Management and Post Market Surveillance processes. Main functional stakeholders include Units, Programs, Global Customer Service, and Manufacturing site Quality. The position is responsible for providing compliant and pragmatic processes and solutions to support Product Risk Management and Post Market Surveillance activities.
The Global Product Risk Management Expert is responsible for the following primary activities:
Typical Studies-Experience, Skills and Qualifications
Skills and Qualifications:
Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).