Sibel Lafci Email & Phone Number

Conducting ISO 13485 Quality Management Systems activities, preparing quality documents such as quality procedures, standards, instructions, etc.,Following up all documents within the framework of the quality system and making necessary revisions and transferring them to the system,Collecting, analyzing and reporting statistical data on quality performance,Planning/implementing internal-external audits, performing and reporting product and system audits,Developing corrective and preventive actions for deviations from quality policies,Accompanying ministry and notified body inspections,Preparation of technical files for Class IIa medical device software,Carrying out CE product certification activities, communicating with approved organizations and following up,Monitoring the relevant regulation and standards and reflecting the changes in the processes,Supporting process management,Execution of software testing processes, writing test scenarios, following the test report,Execution of ÜTS (product tracking system), EUDAMED, TITCK activities,Making and following official correspondence,Preparation of the Ethics Committee and Ministry files for the clinical study with voluntary participants, execution of the approval process,Organizing clinical work,Collecting price offers from CRO companies for the execution of clinical study activities,Making correspondence and process follow-up regarding clinical activities,Execution of personnel processes of İŞKUR on-the-job training program,Preparation of KOSGEB R&D projects documents, execution of support applicationsPreparation of TÜBİTAK 1507 project applications, execution of support processesExecution of exporter union support processes supported by the Ministry of CommerceExecution of call application and support processes in accordance with TUSEB Open project callsTeknokent project applications, personnel entry,

Antalya, Türkiye

Conducting ISO 13485 Quality Management Systems activities, preparing quality documents such as quality procedures, standards, instructions, etc.,

Konyaaltı, Antalya, Türkiye

Conducting ISO 13485 Quality Management Systems activities, preparing quality documents such as quality procedures, standards, instructions, etc.,Following up all documents within the framework of the quality system and making necessary revisions and transferring them to the system,Collecting, analyzing and reporting statistical data on quality performance,Planning/implementing internal-external audits, performing and reporting product and system audits,Developing corrective and preventive actions for deviations from quality policies,Preparation of KOSGEB R&D projects documents, execution of support applications

Supporting SAP go-live processes,Creation of product trees, material cards,To provide post-live maintenance and development services, to fulfill their work, Applied mastery of SAP system design, build and deployment to oversee lifecycle implementations.Offered training to SAP users and delivered continuous support related to implemented solutions.

Making a production plan and creating work orders for the injection molding machines to produce the necessary plastic materials according to the weekly production plan. Transferring the created work orders to the ALS system. Calculation of the performance of injection machines, reporting of malfunctions, reportingDetection of malfunctions in production lines, monitoring of the performance of the lines and reporting to the senior management

Licence, Mathematical Engineer

Barchelor, Management Information Systems, General