The Process Quality Engineer is responsible for implementing and maintaining quality policies/processes to fulfill the internal and external quality management systematic standards.He/she is responsible for quality process improvement and training in Operations.

Quality Process Management - Support Operations Quality Manager and Production Line Manager to set-up, define, validation and maintain the quality targets and tasks - Keep the good communication channel with Global Process Landscape Center - Introduce, develop and update the quality process from Global to localize all kinds of processes relevant for production quality - Create a quality reporting system with SAP Quality Module and demonstrate, track, value the quality information and review whether agreed targets/quality reference number are reached - Organize the quality process review in Operations, drive the quality process continuous improvement - Support NPI in Operations from the aspect of quality. Audit - Implement and review the regular internal and external audit for ISO, Medical Device Direction (MDD), Food and Drug Administration (FDA) and CFDA within Operations and update the sub-processes - Timely complete the improvement actions identified by all kinds of audits and track and complete the corrective action and preventive action (SAPA) program - Organize the Layered Audit in Operation to daily monitor the execution of SOP/PI/TP etc., track the closure of findings and detect the systematic in process through analysis Report - Collect and analyze Quality KPI, submit the reports to Operations management - Use SAPA tools for all investigation and evaluation of quality processes in Operations - Make Process Review Report, define the process improvement opportunity Coaching - Internal process training Others signed by management

学历/Education Bachelor degree in quality management or engineering or a comparable combination of education and experience

相关工作经验/Related experience 3-5 years more of experience in quality management 3 year more of experience in Medical device Industry

专业技能及相关证书 Skills, competencies, and / or certifications

- 行为方面/Behavioral Professional -

Knowledge of quality standards(ISO 9001, ISO 13485, MDD and CFDA) – advanced level

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