סקירה כללית
Position: 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 Direct Manager: Manufacturing Quality Manager Requirements:
• Education: B.Sc. in BiomedicalBiotechnologyChemical Engineering Job skills: * 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) Auditor qualification
– an advantage
• Computer skills: Proficiency in Office products – Must. ERP systems, an advantage.
• Language skills: Fluent English
– Mother tongue level Personality: Team player ,Excellent interpersonal relations, Highly organized and detail oriented, Motivated and committed ,Creative and proactive. Assertive with the ability to effectively lead and drive cross-functional collaboration; capable of confidently interacting with multiple departments, assigning tasks, and ensuring timely execution.
דרישות המשרה
. * 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 d
