Production 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 Production Quality Engineer to join the QA product team.

Job Description:

• Serve as owner of the NCMR process: manage the end-to-end handling of non-conforming materials, products, and processes, including initiation, investigation and corrective/preventive actions in accordance with company procedures and regulatory requirements.
• Monitor NCMR process including quality KPI’s
• Support for non-conformity investigations and assign effective corrective actions for NCMRs and ensure timely closure and documentation.
• Perform / review Root Cause Analysis as part of NCMR process and assign relevant corrective actions.
• Act as QA representative for Manufacturing Quality process
• Conduct quality assurance activities such as data analysis and statistical evaluations, SOP review and approvals, audit preparation
  
  

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

• 2 -5 years of experience in QA/RA, in a medical device or pharma manufacturing company
• Deep knowledge in working according to Medical device regulations and GMP (FDA QSR 820, ISO 13485)
  
  

• Computer skills: Proficiency in Office products – Must. ERP systems, an advantage.
• Language skills: Fluent English - Mother tongue level