Maintenance of the Training Management System Learn4U regarding role and training assignments (as determined by Functional Managers and by the Learning Plan / Qualification Matrix)
Publication of released processes according to their validity date and other relevant items (e.g. training material, interface agreements)
Support for maintaining and improving process and product quality
Support the Audit and CAPA management activities including root cause analysis and effective implementation of CAPA.
Participate in Internal Audit and External Audits using MDSAP methodology
2 to 5 years of overall experience in Quality Assurance activities.
Knowledge of Quality standards like ISO 9001, ISO 13485
Knowledge of Business intelligence tools like, Qliksense, PowerBI etc
knowledge of quality tools for metrics data analysis
Understanding of medical device related document control and training management requirement.
Ability to work in team environment