Be the focal point for production issues, identify the root cause of technical issues and recommend fixes
Handling customer complaints - documentation, investigation and regulatory assessment
Address non-conformances and implementing corrective actions.
Manage suppliers quality, perform supplier audits and manage supplier corrective actions and suppliers
assessment.
Work closely with Production, R D, Suppliers and Operations teams to ensure quality considerations are
integrated into the design and development and manufacturing processes
Training employees on quality issues, root cause and fixes.
Monitor and trend quality metrics, of the entire production cycle such as defect rates, to identify areas for
improvement.
Prepare reports and perform trend analyses.
Lead continuous improvement initiatives to enhance product quality and process efficiency.
Requirements: 3-5 years of experience in quality engineering in Production line in the medical device industry - mandatory.
Education: Engineer/ Practical Engineer in the field of machinery / Industrial/ materials/ chemical/
biotechnology or another related field - mandatory.
Strong understanding of medical device regulations, ISO 13485, FDA QSR, and risk management standards
(ISO 14971).
Technical writing skills, in English, that include quality procedures and TEST plans
High motivation, reliability, integrity and high interpersonal communication skills.
Attention to details, order and organization at a high level, ability to understand specifications, drawings and
data sheets - a must.
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