• 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

Experience

  • 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