summary

ankara, ankara
permanent

job category
manufacturing & production

job details

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.

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.

qualifications
Graduated from Engineering or related technical departments of universities,
Preferably experienced in the Medical Device or Pharmaceutical sector,
Experienced in Quality Assurance processes,
Having taken an active role in Method Validation and Process Validation,
Experienced in FAT, SAT, IQ, OQ, and PQ processes,
Proficient in ISO 13485 and GMP quality systems,
Experienced in CAPA, Change Control, Risk Analysis (FMEA), and root cause analysis processes,
Preferably having taken part in new production line installation, equipment commissioning, or technology transfer projects,
Fluent in English,
Strong analytical thinking skills, problem-solving oriented, prone to teamwork, and possessing advanced communication skills.

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