Production Quality Engineer
Eitan Medical
Description
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
Requirements:
· Education: B.Sc. in Biomedical\Biotechnology\Chemical 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.