Job Summary: Kiwa is a world top 20 leader in Testing, Inspection and Certification (TIC). With our certification, inspection, testing, training and consultancy services, we create trust in our customers' products, services, processes, (management) systems and employees. We do so in a wide variety of markets segments, ranging from construction and energy supply to drinking water, healthcare, food, feed & farming. Kiwa employs over 10,000 people in over 40 countries, in Europe, Asia, the Americas and Oceania. Since 2021 we are a member of SHV Family of Companies. We are looking for a ‘Auditor/Technical Expert(MDR)’ to join our company for our Medical Division, located in Tuzla, İstanbul. About the role:
Opportunities for global opportunities and rotation among more than ore than 10,000 engaged employees, working from over 40 countries can always knock on your door.
We always applaud successes with different reward methods.
- Conducting quality system audits for medical device manufacturers
- Assessment of MDR compliance and review of technical documents
- Providing technical support for decision-making processes related to certification
- Preparation of MDR technical documentation and operation of the quality management system in accordance with the requirements of the Medical Device Regulation MDR 2017/745
- Monitoring regulations regarding medical devices and implementing relevant arrangements.
- Bachelor's/Master's degree in biomedical, biotechnology, engineering, or other science fields
- Minimum 4 years of work experience in the medical device industry, including at least 2 years related to quality management
- Experienced in Design Development, Production Process Control, Document Management, Risk Management, Corrective/Preventive Action Management, and Change Control Management systems
- Knowledge of post-marketing surveillance systems (PMS, PMCF, PSUR, etc.)
- Experienced in ISO 9001, 13485, ISO 14971 CE, and MDR regulations, and actively involved in Quality Management System activities.
- Strong analytical thinking and technical reporting skills
- Excellent written and spoken English skills.
You can constantly improve your personal, professional, and technical competencies by participating in our academy programs that support you and your career.
Opportunities for global opportunities and rotation among more than ore than 10,000 engaged employees, working from over 40 countries can always knock on your door.
We always applaud successes with different reward methods.