Coordination of activities related to Quality and Patient Safety, with a strong focus on value for the patient, including- support and follow-up of quality improvement projects;- coordindation of the safety management system, including incident reporting, root cause analysis, prospective risk analysis and safety culture monitoring and promotion- organizational compliance with JCI standards (2 successful hospital accreditations);- overview of quality & patient safety indicators, orienting the various departments on data collection, benchmarking and analysis methodologies;- monitoring of patient satisfaction/experience and support of patient experience initiatives- supervision of the Quality & Patient Safety Unit, and coordination of decentral Quality & Patient Safety anchors

extension of QRA Compliance activities with Regulatory Affairs responsibilities, incl.- world-wide registration activities for diagnostics- incident reportingMost important projects:- implementation optimised CAPA-system- Risk Management Project

extension of QRA Compliance with responsiblity for Validation activities, incl.- Validation Master Plan- cooridination validation team

- FDA-project: upgrade of Diagnostics Business Unit to sustainable FDA-compliant level- GxP-compliance- coordination of internal and external audits- supplier audits- employee qualification and GMP-trainings

- release of diagnostics batches- review of changes and deviations- internal and external audits

further development Quality System (ISO 9001)