Design Quality Engineer

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