About this opportunity

The primary responsibilities include, but are not limited to, the following areas: implementing, maintaining, and ensuring a compliant quality management system in EMEA region, meeting the requirements of ISO 13485, FDA’s Quality System Regulations (QSR) and Regulations (EU) 2017/745, including management of compliance, global QA projects implementation and execution, change management, , vendor QA assessment and EMEA QMS KPI’s. The scope of the job position contains the facilities in EMEA, and the AFAB EMEA. Sr Quality Assurance Engneer EMEA ensures that projects and directions given by global QA are properly implemented and executed across EMEA. In this role, you will… Ensure that the QMS on EMEA level is compliant with the requirements of ISO 13485, FDA’s Quality System Regulations (QSR) and Regulations (EU) 2017/745. Identify and manage projects to improve the effectiveness of the QMS on EMEA level. Support EMEA functions outside QA-RA to...