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.
  
  

• Education: B.Sc. in Biomedical\Biotechnology\Chemical Engineering or equivalent
  
  

• 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