Responsiblity:Responsible for developing, applying, revising, and maintaining quality standards/procedures to support manufacturing activities. Making sure the GMP and ISO13485 requirements are implemented correctly and followed strictly. ?Continuously fully comply with all GMP standard /ISO 13485 requirements. ?Maintain the local Quality system and implement all quality requirements. Conduct monitoring and trend analysis for QualitySystem implementation in the assigned areas. ?Ensure sufficient processes are in place and being followed for the transfer, production, sustaining, and monitoring of product quality ?Provide guidance on Quality Assurance/GMP/FDA-QSR related topics. ?Responsible to stop further processing in the event of encountering non-conforming products condition. ?Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment ?Develop, coordinate and/or implement root cause problem solving, preventive and corrective actions. Analyzes reports and/or returned products and recommends corrective action. ?May conduct and support Internal and External audits. ?Provide support on Quality procedure set up and validation to product transfer and assist during new product development. ?Be the system owner for QS based on authorization. ?Release RM/Component/Product at first level based on authorization. ?Other tasks assigned by Supervisor.Requirement:?More than 3 years in Quality Assurance or related functional area ?Experienced in GMP or ISO quality systems ?Experienced in machining inspection, method selection, gauge calibration is preferred. Must be able to observe and note minute inconsistencies. ?Must be able to generate, follow, and explain detailed instructions and inspection procedures of the responsible areas accurately. ?Familiar with analytical tools, such as FMEA, process control plan and SPC. ?Familiar with Blueprint/engineering schematic reading and interpretation ?Basic inspection techniques ?Good communication skills and training skills ?Effective interpersonal skills ?Basic PC skills

职位类别： 品质工程师(QA/QC工程师)

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