תיאור המשרה

Summary:
A quality engineer in medical device manufacturing plays a crucial role in ensuring that products meet the required
quality standards and comply with regulatory requirements.
The Quality Engineer is responsible for maintaining and improving the quality of medical devices by implementing
quality assurance processes, conducting inspections and audits, and ensuring compliance with industry standards
and regulations. This role involves working closely with manufacturing teams, design engineers, and regulatory
affairs to ensure that products are manufactured according to the highest quality standards to ensure quality is
maintained at every product lifecycle state, from development through manufacturing and distribution.
Essential Functions
• 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.