Kalite Yönetim Uzmanı

Biomira Medikal San. Ve Dış Tic. A.Ş.

Quality Management Specialist 
Location: Turkey – Istanbul, Ataşehir (Based in Germany)
Company: Phibio GmbH
 
About the Position:

We are looking for a "Quality Management Specialist" who is knowledgeable in the field of medical devices to take part in the production and quality processes of Phibio GmbH, our company operating in the medical sector based in Germany, in its Turkey office. This position is for experienced candidates.

Job Description:

•         Organizing quality control tests of medical products and reporting the results
•         Preparation and updating of technical files for Class II B  and Class III medical devices
•           Carrying out documentation processes in accordance with MDR and relevant international regulations
•          Preparation of necessary documents and records in accordance with the Ministry of Health of the countries to be exported
•          Inspection of products for compliance with relevant technical and legal standards
•         Performing physical and visual box checks
•         Detection and recording of regulatory non-conformities that may occur during or after production(speaking and writing
•         Supporting the preparation processes for internal and external audits
•         Support for training and implementation of ISO 13485, ISO 9001, MDR, GMP and similar quality systems
•         Contributing to continuous improvement and process development studies

Qualifications:

•         Graduated from Chemistry, Chemical Engineering, Biomedical Engineering, Molecular Biology, or similar departments of universities
•          Good command of English (speaking and writing)
•          Knowledgeable and actively worked in the field of medical devices or medicine for at least 2 years.
•         Able to think analytically, careful, meticulous and responsible
•          Open to teamwork, able to communicate effectively with different departments
•          Willing to follow up on documentation and legislation
•          Preferably knowledge of ISO 13485, GMP, ISO 9001, MDR (Class II B and Class III) or similar quality systems

 NOTE: THERE WILL BE AN ENGLISH INTERVIEW STAGE.

The candidate will be subjected to a special interview in terms of MDR and regulation.