Kalite Uzmanı

Randstad Türkiye; Çankaya; On-site; TRY 180,000 - 240,000; Full time

Job summary

Randstad Türkiye is seeking a Quality Specialist based in Ankara for our international medical device partner. You will lead quality processes in new production lines and support commissioning projects.

You will coordinate FAT, SAT, IQ, OQ, PQ, and Method/Process Validation, ensure QMS compliance with ISO 13485 and GMP, and participate in audits, CAPA, Change Control, and continuous improvement.

Qualifications

• Engineering or related technical degree.
• Experience in Medical Device or Pharmaceutical sector.
• Experience with Quality Assurance processes.
• Active role in Method Validation and Process Validation.
• Experience with FAT, SAT, IQ, OQ, and PQ.
• Proficient in ISO 13485 and GMP.
• Experience with CAPA, Change Control, FMEA, and root cause analysis.
• Experience in new production line installation or technology transfer.
• Fluent in English.
• Strong analytical thinking, problem-solving, teamwork, and communication.

Responsibilities

• Carry out quality processes in new production lines and equipment commissioning.
• Lead FAT, SAT, IQ, OQ, PQ activities.
• Coordinate Method Validation and Process Validation studies.
• Support quality activities in new product, process, and technology transfer projects.
• Manage QMS documentation and procedures.
• Execute CAPA, Change Control, FMEA, and deviation management.
• Ensure ISO 13485 and GMP compliance.
• Support internal and external audits.
• Coordinate with Production, Engineering, Automation and other departments.
• Contribute to continuous improvement initiatives.

Skills

Analytical thinking

Problem solving

Teamwork

Communication skills

English fluency

Education

Engineering degree

Job description

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.