Özlem M. Ceyhan

Bis 2009, Quality Manager, Draeger Medical, İstanbul
İstanbul, Turkey

Fähigkeiten und Kenntnisse

Quality Management System
ISO 13485-ISO 9001
93-42 MDD
CE Marking
ETO sterilization
Packaging
CAPA
GMP
Risk Analyse
FDA medical device approval
Biocompatibility
Clinical study
foreign countires registrations

Werdegang

Berufserfahrung von Özlem M. Ceyhan

  • Current 15 years and 3 months, since Mar 2011

    Regulatory Affairs &Quality Manager

    Zimmer

  • Current 16 years and 4 months, since Feb 2010

    QA&RA Mng

    Occlutech Ltd

    To establish ISO 9001&13485 in the İstanbul branch of the company. To join exteranal audit by NB To coordinate clinical study and CE application of the new Class III products To provide QM and GMP tarining for the employee

  • 1 year, Mar 2010 - Feb 2011

    Quality Assurance Manager

    Occlutech Tıbbi Cihaz Sanayi Ltd

  • 6 months, Jul 2009 - Dec 2009

    Quality Manager

    Draeger Medical, İstanbul

    To coordinate and improve IMS Quality Management System and Quality internal -external audits , ISO 9001-13485, ministry of health registration process, to trace goverment process

  • 7 years and 1 month, May 2002 - May 2009

    Regulatory Affairs Manager

    Alvimedica

    To prepare CE design file for the cardiovascular surgery devices ( Balloon Catheter , Stent , Sternumwire, Tubing Set ) for Class III ve Class IIb in accordance with 93-42 MDD, Quality Management System , ISO 9001-13485 , GMP , FDA applications, To join Internat and exteranl audit , CAPA, Customer complaint, pacakaging, sterilization, microbilogical control, cleanroom control

  • 1 year and 6 months, Jul 2000 - Dec 2001

    Technical Manager Asistance

    Enviro Tek

    Ruhsatlandırma ,

Ausbildung von Özlem M. Ceyhan

  • 1 year and 8 months, Sep 2008 - Apr 2010

    MBA

    Maltepe University

    Integrated Marketing Stragety

  • 5 years and 6 months, 1993 - Jun 1998

    İTÜ Chemical Engineer

Sprachen

  • Turkish

  • English

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