Esra TATLI
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Esra TATLI
- Bis heute 3 Jahre und 6 Monate, seit Feb. 2022
QMS Manager
Philips Medical Systems
- Bis heute 6 Jahre, seit Aug. 2019
Founder
ETD Training and Consultancy Ltd.Co.,
We provide professional consulting services for organizations involved in the life cycle of medical devices. Within the scope of our activities, we provide consultancy services on the establishment of quality management system in accordance with ISO13485 standard,preparation for control and certification inspections, completion of preparations for CE certification inspections of medical devices in accordance with European Union medical device legislation,trainings and infrastructure and process validations.
- 2 Jahre und 2 Monate, Jan. 2017 - Feb. 2019
Quality Manager
Medbar Tıbbi Malzemeler Turizm ve San. A.Ş.
• Head of quality department which includes maintaining quality management system, regulatory affairs, CE certification and quality control. o Control and maintain ISO 13485 quality management system, transitioning to 2016 revision of the standard, quality documentation o Control/management of technical dossiers • Working together with engineering department on validations of special processes (EtO sterilization, packaging, clean room infrastructure)
- 6 Monate, Mai 2014 - Okt. 2014
Auditor / Quality Assurance Specialist
ERA Yönetim Test ve Belgelendirme Hizmetleri A.Ş.
• Performing ISO 13485 and ISO 9001 certification and follow-up audits of companies who works in medical device sector • Checking technical dossiers of customers
- 3 Jahre und 9 Monate, Okt. 2009 - Juni 2013
Quality-Manager
Pharmamed Medikal Ürünler San. ve Tic. Ltd. Şti.
- Establishment and maintaining ISO 13485 QMS for Medical Devices and ISO 9001 Quality Management System - Preperation of technical and design dossiers (classification, technical drawings on AutoCAD, risk management (ISO 14971), clinical data evaluation, biocompatibility data evaluation (ISO 10993) ) and CE certification of medical devices acc. to MDD 93/42/EEC
- 2 Jahre, Okt. 2007 - Sep. 2009
Quality Management System Specialist
ERKO Corporate Group
Establishing and performing an integrated Quality Management System including ISO 9001, ISO 22000, ISO 14001 and OHSAS18001 - Quality documentation - Risk management (food related, occupational and enviromental) - Internal audits - Supplier audits - Follow-up customer complaints - Follow-up of corrective and preventive actions
Ausbildung von Esra TATLI
- 2 Jahre und 10 Monate, Sep. 2016 - Juni 2019
Biomedical Technologies
Ege University
MSc Dissertation: CHANGES INTRODUCED BY THE EUROPEAN MEDICAL DEVICE REGULATION WITH NUMBER 2017/745 AND MEASUREMENT OF ADAPTATION LEVEL OF MEDICAL DEVICE MANUFACTURER ORGANIZATIONS IN TURKEY
- 3 Jahre und 10 Monate, Sep. 2009 - Juni 2013
Business Administration
Akdeniz University
MSc Dissertation: "An Application on Differences of ISO 13485 Quality Management System for Medical Devices from ISO 9001 Quality Management System"
- 6 Monate, Sep. 2006 - Feb. 2007
Food Science
University of Copenhagen
- 4 Jahre und 10 Monate, Sep. 2002 - Juni 2007
Food Engineering
Hacettepe University
Sprachen
Türkisch
Muttersprache
Englisch
Fließend
Deutsch
Gut
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