QUALIFICATIONS AND JOB DESCRIPTION
Responsible for the implementation and maintenance of the Quality Management System,
Having taken part in and/or managed the CE certification processes of Medical Devices and/or Pharmaceuticals, having knowledge of the Technical File preparation process for Auditing Institutions and Public Institutions,
- Participated in national and international certification studies,
- Having received ISO 13485 training and preferably the European Union Regulation No. 2017/745 (Medical Device Regulation-MDR),
- Mastering the validation processes,
- Compatible with flexible working hours,
- Prone to teamwork,
- Good at computer use,
- Residing in Ankara,
- Knowledge of ISO 13485 Quality Management System (QMS) Standard and its applications,
- Follows all relevant national and international standards,
- Completing FDA-related application forms
- Compliance checks of relevant medical devices in accordance with the legislation,
- Preparation of Technical Files in appropriate format,
- All kinds of correspondence and process follow-up
