Özlem Kaplan Email & Phone Number

Ankara, Türkiye

• Following the processes according to ISO 13485, ISO 14001, CE, FDA requirements.• Performing Environmental quality management tasks.• Ensuring the continuity and implementation of the quality and environment management systems.• Handling document and record control procedure as WIP Document System admin.• Preparing, reviewing, revising the quality systems procedures, instructions, forms and also quality manual.• Handling the external origin documents by following the standards and revisions.• Performing data analysis for assigned KPIs and objectives.• Handling the CAPA process as System admin (Improvement System)• Handling the NCs of own processes (Correction System)• Handling the training records in QARA group. Giving training to overall company for general training, orientation training (Quality and Environmental Management Systems) according to plan.• Handling the internal audit process.• Preparing the related documentation and certificates for customer request.• Handling the calibration process as System admin (API Pro System)• Making the supplier audits, preparing the report, following the audit issues.• Risk management; participating to the risk management activities as a member of risk management team.• Following the Change Request for own processes.• Handling all the environmental and dangerous goods safety requirements and being a contact person for Ministry of Environment, Ministry of Transport and Infrastructure (ADR). Handling Red On-Line (Environmental and Dangerous Goods Safety Legislation Tracking System), Green Diamond (Sustainability System), iChemistry (Chemical Management System) systems and providing data managing systems from environmental aspects.• Managing sustainability actions within the organization.• Driving and participating in global or local projects.

Ankara, Türkiye

• Fulfilling the requirements of ISO 13485 Medical Devices Quality Management System and to ensure the continuity of the system• Fulfilling the requirements of ISO 14001 Environmental Management System and ensuring the continuity of the system• Ensuring fulfillment and follow-up of CE and FDA requirements, • Managing document control (WIP Document System)• Managing the CAPA process• Managing the internal audit process• Managing the calibration process• Handling the external origin documents• Providing orientation training and general trainings• Taking part in supplier audit• Executing Environmental Legislation practices (Declarations, ÇED and Environmental Permit Applications, preparation of Waste Management plans, all processes related to waste management, etc.)• Providing data to global sustainability, chemical, environmental legislation tracking systems and managing systems• Follow-up activities as a company responsible for Dangerous Goods Safety issues• Conducting Occupational Health and Safety activities (between 2016-2020)

Ankara, Türkiye

• Fulfilling the requirements of ISO 9001 Quality Management System and ensuring the continuity of the system • Fulfilling the requirements of ISO 13485 Medical Devices Quality Management System and ensuring the continuity of the system • Meeting the requirements as TUBITAK project manager (Project name: Heater Integration into Anesthesia Device CO2 Absorber System and Reduction of Moisture Percentage Due to Expiration)• Preparation of CE Technical File• Preparing a file for product sales through DMO • Making data entries to the Ministry of Health Product Tracking System, following system requirements• Conducting Trademark/Patent Application studies • Managing TSE Service Competence Certificate processes• Ensuring the requirements of Occupational Health and Safety activities within the company• Conducting Human Resources activities

Ankara, Türkiye

Conducting research and development studies of clinical biochemistry kits used as in vitro diagnostics.

Master Of Science - Ms, Analytical Chemistry

Bachelor'S Degree, Chemistry