Senior Development Quality Engineer נתניה 152315
Senior Development Quality Engineer נתניה 152315
01/03/2022· As a Senior Development Quality Engineer, you will provide QA oversight and guidance to R&D as to the required deliverables to ensure compliance throughout product development cycle
· You will act as a QA leader of change controls initiated throughout the project, and for changes related to the QMS.
· You will be focal point & SME for quality related aspects as part of R&D processes and will attend R&D project routine meetings as the QA representative.
· You will establish quality methodologies for the future product (control plans & quality plans), ensures that the products meet the predetermined quality specifications, customer, and regulatory requirements.
· You will be the project QA representative in front of the pharmaceutical partners
· Review and approve deliverables and additional documents which are required for the R&D projects
· Conduct QA activities relating to data
Education:
o B.Sc in Engineering in one of the following fields: Medical device Quality\ Biomedical \ Biotechnology or in Bioscience education – advantage
o CQE/CMQ from ASQ – advantage
· Job skills:
o 3-4 years of experience in QA, preferably with R&D projects, in a medical device or pharma manufacturing company according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
o Experience working in medical device product development (product design) and manufacturing (process design, process validation, and production).
o Auditor qualification - an advantage
o Experience in supporting sterile production and clean rooms - an advantage
· Computer skills: Full control of all office applications
· Language skills: English- writing and verbal skills- advantage
· Personality: Excellent communication and leadership skills, organized, motivated
* משרה מס׳ #152315 מיועדת לגברים ונשים כאחד
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