Quality Assurance Engineer Medical Device

• 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.
דרישות התפקיד
• 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.