and recommend fixes
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
Be the focal point for production issues, identify the root cause of technical issues 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: 5-7 years of experience in quality engineering in Production environments HLA (High Level Assembly)
Advantage - Medical device/ Defense industry experience (HLA, capital equipment).
Deep understanding of production processes from Incoming Inspection through assembly, in-process testing,
functional Jigs, Final Integration and OQC (Outgoing Quality Check).
Deep understanding of manufacturing processes (e.g., machining, sheet metal processing, plastic
manufacturing, PCB/PCBA and cables).
Education: Engineer/ Practical Engineer in the field of machinery / Industrial/ materials/ chemical/
biotechnology or another related field - mandatory.
Strong understanding of working in medical device regulation environment (ISO 13485, FDA QMSR, and risk
management standards (ISO 14971)).
Technical writing skills, in English, that include quality procedures, TEST plans, PFMEA etc.
This position is open to all candidates.