Ayşe Bora Email & Phone Number

Turkey

İzmir, Turkey

- To take part in customer relations and quality issues in direct connection with customer.- Taking an active role in the execution of foundry and machining operations quality control and quality assurance activities.- Managing customer complaints.- Receiving customer feedback and complaint reports and analyzing them with 8D problem solving methodology.- To carry out corrective action, preventive action activities.- Making tolerance/NCR/SDR applications for defective parts. Informing customers about the corrective actions related to these.- Leading customer audits and certifications.- To carry out internal process/process and supplier audit activities related to quality management systems.- To follow project management, continuous improvement and new product commissioning activities.

İzmir, Türkiye

- Carrying out and monitoring the continuous improvement of ISO 9001:2015 and ISO 13485:2016 quality management systems - Improving and developing the risk management processes in accordance with the requirements of the ISO 14971:2019- Issuing technical documentation requirements during the IVDR transition process- Planning, organizing and performing internal audits - Taking an active role in second- and third-party auditsAccomplishments/Key Projects Technical documentation/CE audit process*Successfully implemented internal audit system and performing in accordance with new system*Successfully prepared post market surveillance plan in accordance with new regulations*Improved maintenance and repair process and calibration, verification, validation process in accordance with new regulations*Improved risk management system within products lifecycle in accordance with ISO 14971:2019

İzmir, Türkiye

- Ensuring that the various quality management systems are under control and that the activities are carried out in accordance with the standards and norms in force - Designing, planning, implementing and continuous improvement of ISO 9001:2015 and ISO 13485:2016 quality management systems- Coordinating and consulting teams and team leaders to ensure they follow the processes.- Carrying out the implementation and improvement of cGMP guidelines requirements.- Creating, monitoring and improving the quality risk management system - Organizing Validation (process and cleaning validations) / qualification (production equipment) studies with other departments and following up- Executing deviation (non-compliance), corrective action and change control management systems.- Organizing and performing the internal audit process- Performing action planning for the nonconformities detected in the results- Creating the system that examines customer feedback, complaints and satisfaction notifications- Organizing the procedures to be applied for returned products and following up- Making annual product evaluation and to evaluating the obtained data in improvement and development studies - Coordinating management review meetings, reporting meeting outputs- Taking an active role in second- and third-party auditsAccomplishments/Key Projects *Successfully implemented ISO 13485:2016 management system together with medical device design and prepared technical documentation in accordance with new regulations*Achieved to design and initiated the complaint management process in line with company objectives

Adana, Türkiye

Accomplishments/Key Projects* Successfully started the export processes*Successfully took responsibility for the application improvement and follow-up processes of the management systems carried out with consultancy and achieved to take over the process from the consultant-internalized the process*Achieved to create the mixes used with the supply of raw materials and greatly reduced the expense in the items of food additives consumed, instead of supplying ready mixes