【职位描述】
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，已经对退回件的处理。
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. 根绝授权作为质量系统负责人。
Release RM/Component/Product at *** 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。

【任职要求】
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