Auditor/Technical Expert(MDR)
On-siteIstanbul, Istanbul, Turkey
Istanbul, Istanbul, TurkeyOn-siteFull TimeMasters DegreeEnterprise
Full TimeMasters DegreeEnterprise
Job Summary
Conduct quality system audits for medical device manufacturers and assess MDR compliance by reviewing technical documents. Prepare MDR technical documentation and operate the quality management system in accordance with Medical Device Regulation 2017/745 requirements. Provide technical support for certification decision-making processes while monitoring regulations and implementing relevant arrangements. Monitor post-marketing surveillance systems including PMS, PMCF, and PSUR. Join our Medical Division in Tuzla, İstanbul, with a Bachelor's degree in engineering and minimum four years of medical device industry experience.
Required Qualifications
- Bachelor's/Master's degree in Mechanical Engineering, Electrical-Electronics Engineering, Mechatronics Engineering, Computer Engineering, or related engineering fields
- Minimum 4 years of work experience in the medical device industry
- At least 2 years related to quality management
- Experience in active medical devices
- Experience in Design Development
- Experience in Production Process Control
- Experience in Document Management
- Experience in Risk Management
- Experience in Corrective/Preventive Action Management
- Experience in Change Control Management systems
- Knowledge of post-marketing surveillance systems (PMS, PMCF, PSUR, etc.)
- Experience in ISO 9001
- Experience in ISO 13485
- Experience in ISO 14971 CE
- Experience in MDR regulations
- Active involvement in Quality Management System activities
- Strong analytical thinking and technical reporting skills
- Excellent written and spoken English skills
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