Esra TATLI

Angestellt, QMS Manager, Philips Medical Systems
İzmir, Türkei

Fähigkeiten und Kenntnisse

ISO 13485
Lead Auditor
Quality Assurance
Medical Device
CE Certification
93/42/EEC
Clean Room Validation - ISO 14644
Ethylene Oxyde Sterilization - ISO 11135
QMS
MDR
2017/745/EU
Beratung

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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