risk management engineer

yayınlanma
şimdi başvur

iş ilanı detay

yayınlanma
lokasyon
antalya
sektör
Mühendislik
referans numarası
6461

iş tanımı

We are looking for a "Risk Management Engineer" for our multinational customer : Maquet Getinge who operates in the medical sector.

Ensuring the risk management process in accordance with applicable standards and regulations.

Creates, reviews and maintains risk management file (RMF) according to established procedures and relevant regulations. (MDR / 21CFR820)

Implementation of ISO 14971 in the internal risk management process for the medical device during the entire life cycle of the product.

Actively participates in R&D study activities, contributing to the identification and assessment of the key risks.

Preparation of benefit / risk assessments in collaboration with the medical experts.

Maintenance of the risk management tool used.

Support of the clinical evaluation studies.

nitelikler

Bachelor’s degree in Engineering; preferably Industrial / Mechanical/Material Engineering, Biomedical Engineering.

Excellent command of both written spoken English; German is an asset.

Experience in product risk management in medical technology is an asset.

Experience with the relevant standards (DIN EN ISO 14971, 13485; IEC 60601-1) in the field of medical technology is desirable.

Knowledge/experience of/with ISO 13485.

Experience in using a risk analysis tool is desirable.

Good knowledge of MS Office applications.

Able to work with multinational teams.
İşbu iş ilanına başvurmadan önce KVKK Aydınlatma Metni linkinde bulunan “aydınlatma beyanını” okumanız gerekmektedir. İşbu iş ilanına başvurmanız durumunda bahsedilen aydınlatma beyanını okuduğunuz ve kabul ettiğiniz addedilecektir.