MDR Auditor & Medical Device Technical Expert

Kiwa Group; Tuzla; On-site; TRY 600,000 - 800,000; Full time

Job summary

Kiwa Group, based in Tuzla, Istanbul, seeks an Auditor/Technical Expert (MDR) to join our Medical Division. You will conduct quality audits for medical devices, assess MDR compliance, and support certification decisions, aligning technical documents with MDR requirements.

Experience with ISO 9001, 13485, and ISO 14971 is essential. Ideal candidates will have 4+ years in the medical device sector, strong analytical skills, and excellent English communication.

Qualifications

• Bachelor's or Master's degree in an engineering field relevant to medical devices.
• Minimum 4 years in the medical device industry, with at least 2 years in quality management.
• Experience with active medical devices and QMS processes.
• Familiarity with MDR and related standards (ISO 9001, 13485, ISO 14971 CE).
• Strong analytical thinking and technical reporting skills.
• Excellent written and spoken English.

Responsibilities

• Conduct quality system audits for medical device manufacturers.
• Assess MDR compliance and review technical documents.
• Provide technical support for certification decision-making.
• Prepare MDR technical documentation and operate the QMS per MDR 2017/745.
• Monitor medical device regulations and implement relevant arrangements.

Skills

Quality management

Analytical thinking

Technical reporting

English proficiency

Regulatory knowledge

Education

Bachelor's/Master's degree in Mechanical Engineering, Electrical-Electronics Engineering, Mechatronics Engineering, Computer Engineering

Job description

Kiwa Group, based in Tuzla, Istanbul, seeks an Auditor/Technical Expert (MDR) to join our Medical Division. You will conduct quality audits for medical devices, assess MDR compliance, and support certification decisions, aligning technical documents with MDR requirements.

Experience with ISO 9001, 13485, and ISO 14971 is essential. Ideal candidates will have 4+ years in the medical device sector, strong analytical skills, and excellent English communication.