♦ Receive and establish production lines transferred from Israel to China, including process equivalency verification and pilot runs approved by Engineering Israel.
♦ Improve manufacturing processes on the local line — coordinated with Israel processes and approved by the Engineering Manager, per ECO procedure.
♦ Perform process re-validation (IQ/OQ/PQ) following changes in equipment, location, or parameters, including protocols and reports for approval by Israel.
♦ Support NPI activities for products localized at China sites & CMO`s - stage-gate participation, local pilot builds, DFM feedback to Engineering Israel.
♦ Manage production nonconformances (NCR): containment, segregation, root cause investigation, corrective actions (CAPA), and return-to-production support in coordination with QA and Engineering Israel.
♦ Identify and evaluate local suppliers, including supplier audits and assessment reports.
♦ Technical management of subcontractors: process control, specification compliance, performance monitoring.
♦ Responsible for translation and adaptation of production documentation for the local line (work instructions, drawings, inspection specifications), aligned to the controlled revision of source documentation.
♦ Full member of the Engineering team — when local workload permits, receives assignments from the Engineering Manager, Israel. Structured weekly report: line status, open nonconformances, risks.