Auditor/Technical Expert(MDR)

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

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

• 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.

Do you have what it takes?

• 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, including at least 2 years related to quality management,
• Experienced in active medical devices,
• 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.

What can you expect from us in return?

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 orethan 10,000 engaged employees, working from over 40 countries can always knock on your door.

We always applaud successes with different reward methods.