Design Quality Engineer

5 days ago

Netanya Center District, Israel Eitan Medical Full time ₪104,000 - ₪130,878 per year

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:

  • 2 -5 years of experience in QA/RA, preferably with R&D projects, in a medical device or pharma manufacturing company
  • Deep knowledge in working according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
  • Auditor qualification - an advantage
  • Computer skills: Proficiency in Office products - Must
  • Language skills: Fluent English - Mother tongue level
  • Personality:
  • Team player
  • Excellent interpersonal relations
  • Highly organized and detail oriented
  • Motivated and committed
  • Creative and proactive

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