Quality Assurance Assistant

Turklab Tıbbi Malzemeler San. Tic. A.Ş.

In 1996 Turklab is established in Izmir as the first and only Turkish manufacturer of In Vitro Diagnostic Tests. We are now looking for strong minded, hardworking individuals to join our growing team,

• Bachelor’s degree (preferably in engineering)
• Preferably 3 years of experience in Quality Assurance Management in medical device industry
• Knowledge of ISO 13485 and GMP
• Experienced in internal and external auditing
• Preferably knowledge of Medical Device Regulatory requirements and risk analysis according to ISO 14971
• Good command of written and spoken English
• Advanced knowledge in MS Office applications
• High level of attention to details and accuracy
• Strong interpersonal skills and problem solving ability
• High interpersonal, communication and presentation skills
• No military obligation for male candidates

İŞ TANIMI

• Developing, reviewing and keeping update QMS documentation, as needed,
• Preparing records needed for the quality management system according to relevant international and national standards,
• Assisting in preparation of all product files and activities related to the quality management system and IVD medical device regulations,
• Registration of IVD products in national database, and maintain their registration by updating changes,
• Researching literature and reviewing database periodically for products and PMS activities.