The Engineer will be a part of the Quality and Regulatory department, working as part of the QA team.
Education: face="Times New Roman" size=1> B.Sc in Engineering in one of the following fields: Quality\ Biomedical \ Biotechnology or in Bioscience education
At least 2 years’ experience in QA or RA, preferably with R&D projects, in a medical device or pharma manufacturing company according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
Proven experience in Audits ( CE, FDA)
Experience working in medical device product development (product design) and manufacturing (process design, process validation, and production).
Full control of all MS-Office applications
Auditor qualification - an advantage
Experience in supporting sterile production and clean rooms - an advantage
Computer skills: Full control of all MS-Office applications
Language skills: Fluent English - writing and verbal.
Ability to work under pressure and in tight schedules
Ability to work in Multidisciplinary work opposite various stakeholders internally and externally
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