Position: QA R&D Engineer – Temp Position

Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home.

We are looking for an excellent QA R&D Engineer to join our pharmaceutical solutions unit

Job Description
• Support & provide QA oversight on all R&D activities
• Be the focal point & SME for quality related aspects as part of R&D processes
• Attend R&D project routine meetings as the QA representative.
• Establish QA methodologies for design transfer (control plans & quality plans).
• Review and approve deliverables and additional documents which are required for the R&D projects
• Act as a QA representative of change controls initiated throughout the R&D products and for commercial products and for changes related to the QMS.
• Improvements of R&D procedures and practices
• Additional QA activities as required.

Direct manager: VP... QA

Requirements:

Job Requirements:
• Education:
• B.Sc in Engineering in one of the following fields: Quality\ Biomedical \ Biotechnology or in Bioscience education
• Job skills:
• 2-5 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)
• Experience working in medical device product development (product design) and manufacturing (process design, process validation, and production).
• Full control of all MS-Office applications
• 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.
• Personality:
• Ability to work under pressure and in tight schedules
• Ability to work in Multidisciplinary work opposite various stakeholders internally and externally
Netanya Israel

Salary Criteria