Aufgabe:
* Implementation of ISO 14971 * Release of all Risk Management procedures, instruction and forms * Training of the Risk Management process as needed * Support of New Product Development, Product Care and Compliance projects * Support all activities where risk management are needed (CAPA, NCs, validation, QMS) * Act as Chair of the IDD Risk Management Board: * Facilitates/ supports Risk Management meetings in order to evaluate risks and update risk files; * Represents the CoE Autoimmunity and coordinates all RM related projects for Freiburg in the ImmunoDiagnosticsDivision (IDD) * Coordinates all Risk Management Process interfaces * Drives the ongoing Risk Management Remediation Project * Risk Management ReportingQualifikation:
* University degree in natural or pharmaceutical science (health science, biology, biochemistry area) with relevant professional experience * Strong theoretical and practical know how in Risk Management (ISO 14971) * Good Quality management background (ISO 13485, QSR, MDR, IVDR) * Many years of experience in production within Medical Devices, IVD or pharma environment * People management, communication and problem solving skills * Experienced in Project Management * Independent and well-structured approach of tasks * Excellent spoken and written language skills in German and English * Auditor certification is a plusWeitere Angebote in den Bereichen:
