Location: GOTEBORG, Sweden
Position Type: VIE
Job Function: Quality
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.
Joining bioMérieux is choosing to be a part of an innovative company with a long term vision, committed to the service of public health and carried out with a human-centered corporate culture.
Our Company offers numerous opportunities for professional development. You want to help save lives across the globe? Join the 13,000 employees of bioMérieux!
As a Quality Coordinator and Vigilance Support, you will support Quality Management System (QMS) for the Northern European Countries (NEC) : UK, Benelux, Scotland, Ireland, Norway, Finland, Sweden and Regulatory Compliance for the NOR subsidiary.
What will be your missions within bioMérieux ?
Update QMS documentation, follow up data analysis with KPIs and support the Management Review Process by performing trending analysis.
Assist in the implementation of CAPAs, Change Management and Supplier Approval process.
Create and support training programs with presentations.
Plan and assist in internal/external audits and the implementation of external certifications.
Coordinate customer satisfaction survey’s implementation and support Quality Management Representatives (QMRs) in their follow up.
Coordinate improvement projects and support QMRs for the deployment of Quality Induction Process.
Set up and follow up Field Corrective actions and incidents.
Answer requests from Competent Authorities, customers and third parties in a timely manner and regarding regulatory compliance.
Monitor the local regulatory environment and report Vigilance KPIs to management.
Ensure that vigilance softwares are up to date regarding local regulatory environment.
Who are you ?
You have at least a bachelor of Science Degree in organization, quality, science or relevant area. Masters’ degree is preferred.
Ideally, you have two years of experience in Quality Management, Auditing and Compliance.
You have an excellent knowledge of Microsoft Office, SAP is a plus.
You have excellent verbal and written communication skills with an ability to motivate and lead projects within all levels of the organization.
You have the ability to analyze and use data to drive process improvements.
You are multitask, organized and adept to changes in a multicultural environment.
You are fluent in English.
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 13 000 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.