QA Product Engineer

Position: Product 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 Product Design Quality Engineer to join the QA product team.

Job Description:

• As a Product Quality Engineer, you will be the focal point for R&D projects.
• You will attend R&D project routine meetings as the design 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 design QA representative.
• Act as Manage NCMR process
• Initiate and implement NCMRs for non-conforming materials/products/process including corrective actions
• Involve 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
  
  

• 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