Quality Specialist

Randstad Türkiye

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

Job Description

• 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.