Auditor/Technical Expert(MDR)

Kiwa Türkiye; Fatih; On-site; TRY 300,000 - 600,000; Full time

Job summary

Kiwa Türkiye, Tuzla/İstanbul’da sağlık sektörü için MDR uyumlu kalite yönetim sistemleri üzerinde çalışan bir Auditor/Technical Expert arıyor. Aday, tıbbi cihazlarda kalite sistemleri ve düzenleyici gereksinimlerle ilgili deneyime sahip olmalıdır.

Görevler arasında kalite denetimleri yürütme, MDR uyumunu sağlama ve teknik dokümantasyonu hazırlama yer alır. İleri düzey İngilizce becerisi beklenir; uluslararası çalışmalar ve gelişim fırsatları mevcuttur.

Qualifications

• Medikal cihaz sektörüyle ilgili en az 4 yıl tecrübe (kalite yönetim sistemi odaklı).
• ISO 9001/13485/14971 ve MDR mevzuatlarına aşinalık ve uygulama bilgisi.
• İleri düzey İngilizce yazılı ve sözlü iletişim becerisi.

Responsibilities

• Tıbbi cihaz üreticileri için kalite sistem denetimleri yürütmek.
• MDR uyumluluğunun değerlendirilmesi ve teknik dokümanların gözden geçirilmesi.
• Sertifikasyon karar süreçlerinde teknik destek sağlamak.
• MDR 2017/745 gerekliliklerine uygun MDR teknik dokümantasyonu hazırlamak ve kalite yönetim sistemini işletmek.
• Tıbbi cihaz mevzuatlarını izlemek ve ilgili düzenlemeleri uygulamak.

Skills

İngilizce yetkinliği

ISO 13485 bilgisi

Education

Mühendislik lisansı/yüksek lisans (Mekanik, Elektrik-Elektronik, Mechatronics, Bilgisayar)

Job description

İş Özeti

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.

İş Tanımı

• 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.

İş Gereklilikleri

• 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.

Beklentileriniz

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.