Design Quality Engineer
Eitan Medical
Description
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 Design Quality Engineer to join the QA product team
Job Description:
As a Design Quality Engineer, you will be the focal point for R&D projects' new products.
· You will attend R&D project routine meetings as the product QA team representative.
· You will review and approve deliverables and additional documents which are required for the R&D projects according to internal SOPs and regulatory requirements.
· You will participate in risk-evaluation processes related to R&D projects as the product QA representative.
· Act as a manager of change controls initiated throughout the R&D products and for commercial products.
· Conduct QA activities relating to data analysis and statistics, calibrations, SOP reviews and approvals, audit tasks and support of non-conformity investigations.
Requirements
· Education: B.Sc. in Biomedical\Biotechnology\Chemical Engineering or equivalent
Job skills:
o 2 -5 years of experience in QA/RA, preferably with R&D projects, in a medical device or pharma manufacturing company
o Deep knowledge in working according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
o Auditor qualification - an advantage
· Computer skills: Proficiency in Office products - Must
· Language skills: Fluent English - Mother tongue level
· Personality:
o Team player
o Excellent interpersonal relations
o Highly organized and detail oriented
o Motivated and committed
o Creative and proactive