Quality Engineer | Advanced Medical Equipment | Northern Israel
Machine translation — original language: Hebrew.Show original
A leading company in the field of advanced medical equipment, operating in global markets, is recruiting a Quality Engineer to join the Quality Department.
What does the role include?
- Maintenance and improvement of the Quality Management System (QMS)
- Working in accordance with ISO 13485, FDA, and MDR
- Handling NCR, CAPA, and customer complaints
- Participation in internal and external audits
- Management of quality documentation and support for ECO and Design Transfer processes
- Working with suppliers and the regulatory department
- Performing quality measurements and preparing reports
Requirements:
- Bachelor's degree in Quality Engineering
- At least 2-3 years of experience in quality within the medical device industry
- Knowledge of ISO 13485 and risk management according to ISO 14971
- Familiarity with FDA 21 CFR Part 820 and EU MDR
- High level of English
- Analytical ability, order, precision, and a Hands-on approach
Location: Northern Israel | Full-time position