KEY RESPONSIBILITIES / DUTIES主要职责:

• 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. 建立，应用并维护质量标准/流程，以支持制造活动。确保GMP和ISO13485要求得到维护和遵守。
• Continuously fully comply with all GMP standard /ISO 13485 requirements. 始终遵守GMP和ISO13485要求。
• Maintain the local Quality system and implement all quality requirements. Conduct monitoring and trend analysis for Quality System implementation in the assigned areas. 维护质量体系，满足质量体系要求。在职责区域监控质量体系的完成情况。
• Ensure sufficient processes are in place and being followed for the transfer, production, sustaining, and monitoring of product quality 确保在项目转移，生产过程中流程得到有效维护和实施，以确保产品质量
• Provide guidance on Quality Assurance/GMP/FDA-QSR related topics. 对质量保证/GMP/FDA-QSR提供指导。 · Responsible to stop further processing in the event of encountering non-conforming products condition. 在产生不良品情况下，必要时，负责停止后续生产活动。
• 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 设计检验方法，测试方法，评估测试方法的适用性。
• Develop, coordinate and/or implement root cause problem solving, preventive and corrective actions. Analyzes reports and/or returned products and recommends corrective action. 负责主导或协调质量问题的根本原因分析，改进措施和预防措施制定，以及对退回件的处理。
• May conduct and support Internal and External audits. 主导或支持内外部审核活动。
• Provide support on Quality procedure set up and validation to product transfer and assist during new product development. 支持质量体系的建立和产品转移项目，协助产品开发过程。
• Be the system owner for QS based on authorization. 根据授权作为质量系统负责人。
• Release RM/Component/Product at first level based on authorization. 根据授权放行原材料/零部件/成品。
• Other tasks assigned by Supervisor. 被主管分派的其它工作。

REQUIRED SKILL SET岗位技能：

• Must be able to observe and note minute inconsistencies. 能够识别不符合项
• Must be able to generate, follow, and explain detailed instructions and inspection procedures of the responsible areas accurately. 能够精确地开发，执行，说明检验流程。
• Familiar with analytical tools, such as FMEA, process control plan and SPC. 熟悉分析工具，如FMEA, 控制计划， SPC
• Familiar with Blueprint/engineering schematic reading and interpretation 有较强理解工程图纸能力。
• Basic inspection techniques 基本检验技能
• Good communication skills and training skills 较强沟通能力和培训技能
• Effective interpersonal skills 有效的人际沟通能力
• Basic PC skills 基本计算机操作技能

RELEVANT EXPERIENCE 经验要求：

• More than 3 years in Quality Assurance or related functional area 3年以上质量相关经验
• Experienced in GMP or ISO quality systems GMP或ISO质量体系相关经验
• Experienced in machining inspection, method selection, gauge calibration is preferred. 机加工经验，测量方法制定经验，有量具校验相关经验更佳

EDUCATION 教育背景：

• B.S. in engineering or engineering related discipline 工程本科或相关专业