Auditor/Technical Expert(MDR)

Kiwa Türkiye; Fatih; On-site; TRY 150,000 - 240,000; Full time

Benefits offered by this job

Global çalışma fırsatları

Job summary

Kiwa Türkiye, Medikal Bölümü için MDR uyumlu denetimler ve teknik uzmanluk gerektiren bir pozisyon arıyor. Tuzla, İstanbul’daki merkezde çalışacak olan bu rolde kalite sistemi denetimlerini yürütüp MDR dokümantasyonunu hazırlayacaksınız.

Mevcut gereklilikler: mühendislik alanında lisans/yüksek lisans, en az 4 yıl deneyim ve MDR/ISO standartlarında bilgi; İngilizce yetkinlik şarttır. Küresel fırsatlar ve prestijli çalışma ortamı sunulmaktadır.

Qualifications

• Mühendislik alanında Lisans veya Yüksek Lisans derecesi (belirtilen dallardan biri).
• Medikal cihaz endüstrisinde en az 4 yıl deneyim; kalite yönetimi konusunda en az 2 yıl.
• Aktif medikal cihazlarda deneyim ve MDR, ISO 9001/13485, ISO 14971 CE bilgi ve MDR uyumluluğu.
• Güçlü analitik düşünce ve teknik raporlama becerileri.
• İleri düzeyde İngilizce yazılı ve sözlü yetkinlik.

Responsibilities

• Medikal cihaz üreticileri için kalite sistemi denetimlerini yürütmek.
• MDR uyumluluğu değerlendirmesi ve teknik belgelerin gözden geçirilmesi.
• Sertifikasyon karar süreçleri için teknik destek sağlamak.
• MDR teknik dokümantasyonu ve kalite yönetim sistemi çalışmalarını hazırlamak.
• Medikal cihaz mevzuatını izlemek ve ilgili önlemleri uygulamak.

Skills

Analitik düşünce

Teknik raporlama

İyi İngilizce yazılı ve sözlü beceri

Education

Mühendislik alanında Lisans veya Yüksek Lisans (ör. Makine, Elektrik-Elektronik, Mechatronik, 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.

• 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 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.

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.