A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) 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.
bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l'Étoile, near Lyon, in France.
Our Craponne site is looking for a Global Post Market Surveillance Expert who will work within the Quality Design & Life Cycle Management department and will be attached to the Director, Global Quality, Product Development and Lifecycle Management within a team of 4 co-workers. The role supports the Global Quality department to ensure adherence to Quality System requirements and applicable standards (e.g., ISO 9001 and 13485).
Main functional stakeholders include Programs, Regulatory Compliance Manufacturing site Quality and Subsidiaries. This position is responsible for providing compliant Post Market Surveillance reports. What will be your responsibilities at bioMérieux ?
Who are you?
- Ensure that Quality System processes, specifically around Post Market Surveillance are implemented in adherence with applicable regulations and standards.
- Schedule, Plan, Coordinate and consolidate Post Market Surveillance Reports and Product Safety Update Reports. Ensure follow-up on actions taken as a result of the report(s) analysis.
- Establish and maintain relationships with external and internal stakeholders to ensure that requirements are understood and are being achieved.
- Assist with other Post Market Surveillance activities as requested
- Bachelor's degree in a technical or life science (e.g., biology), you have at least 5 years of Quality experience ideally in the In-vitro Diagnostic field or related industry.
- Strong leadership and communication skills.
- The ability to multitask and provide direction/guidance by providing logical and least burdensome approach to fix quality issues and assist in the implementation of the needed improvements.
- Strong interpersonal and communication skills required.
Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment
Our internal mobility policy offers numerous opportunities for each of our 12 000 employees to blossom throughout their career, while respecting each employee's individual talents as well as their personal and professional development.
At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.
Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.
Job ID: 13126