kalite uzmanı.

We are seeking a 'Quality Specialist' based in Ankara for our international business partner operating in the medical device sector.

Carrying out quality processes in new production line and equipment commissioning projects.
Taking an active role in FAT, SAT, IQ, OQ, and PQ processes.
Conducting or coordinating Method Validation and Process Validation studies.
Supporting quality activities in new product, process, and technology transfer projects.
Managing quality procedures, instructions, and documentation processes within the scope of the Quality Management System (QMS).
Executing CAPA, Change Control, Risk Analysis (FMEA), and deviation management processes.
Ensuring the effective implementation of quality systems in line with ISO 13485 and GMP requirements.
Supporting internal and external audit processes.
Managing quality processes in coordination with Production, Engineering, Automation, and other relevant departments.
Contributing to continuous improvement initiatives.