Medical Device Auditor/Expert İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
- As Auditor, audits the quality management system of medical device manufacturers based on theISO 13485 standard and applicable regulatory requirements of the EU, Canada, Japan, USA, Brazil and/or Australia.
- As Expert for medical devices, participates in audit teams as technology/ product expert, as well as performs regulatory technical documentation or design dossier reviews of medical devices sold to the EU market.
- Tasks (including preparation, on-site and remote conformity assessment and reporting to the certification office) are carried out within the processes of the accreditation holder.
- Typically, at least 60% travel is involved, mostly in Turkey, Middle East and Europe.
- University Degree in a relevant scientific or engineering discipline, preferably electrical, electronic, mechanical, or bioengineering, physics or biophysics, biology, biotechnology, pharmacy, medicine or equivalent
- Experienced at least 3 year in medical device auditing
- Trained lead auditor or internal auditor
- Trained in ISO 13485 standard and having qualification Lead Auditor or internal Auditor
- Trained in the medical device regulatory requirements in the EU, Canada, Japan, USA, Brazil and/or Australia
- Working knowledge of medical device technical standards
- Working knowledge in production technologies
- Have strong knowledge about Medical device risk management, e.g. ISO 14971
- Experienced in Audit principles, practices, and techniques
- Excellent communication skills as well as fluency in English
- Have no travel restrictions
Benzer İş İlanları
Biyomedikal Sorumlusu
Biyomedikal Hizmetler Sorumlusu
Biyomedikal Sorumlusu
Biyomedikal Teknikeri
Biyomedikal Mühendisi
Biyomedikal Mühendisi
Biyomedikal Uzmanı / Sorumlusu
Biyomedikal Teknikeri
Medikal Cihaz Satınalma Uzmanı
Biyomedikal Teknikeri
Biyomedikal Sorumlusu
Senior Digital Design Engineer
Biyomedikal Teknikeri
Instrumentation & Control Engineer
AGS MEDİKAL ÜRÜNLERİ İTHALAT İHRACAT TİCARET ANONİM ŞİRKETİ Biomedical Engineer
Biyomedikal Mühendisi
Biyomedikal Departman Yöneticisi
Biyomedikal Uzmanı
