Job Description

Work Flexibility: Onsite

• Continuously fully comply with all GMP and Regulatory requirements.

持续完全符合所有的GMP和法规要求

• Responsible to stop further processing in the event of encountering non-conforming products condition and lead customer complaint handling

当发生不合格产品时，负责停止进一步流转, 领导客户抱怨的处理

• Implement Stryker Corporate Quality policies and standards. Ensure compliance to GMP and ISO requirements

执行史赛克总公司质量政策和标准，确保符合GMP和ISO要求

• Ensure sufficient processes are in place and being followed for the transfer, production, and monitoring of product quality, including but not limited to inspection guide sheet, gage and inspection equipment management.

确保所有流程是适当的并在新项目转移或量产中被执行， 监控产品质量，包括但不限于检验作业指导书检具及检验设备的管理。

• Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products.

定义、说明和/或批准检验测试标准、方法、程序的执行， 并评估公司产品的精确度、准确度和可信赖度

• Involved in developing, modifying, and executing regulatory related company guidelines and procedures.

参与法规相关的公司质量方针和程序的建立、修订和执行

• Will train others on GMP, ISO, Quality Assurance/Regulatory Affairs topics.

对员工进行GMP、 ISO、质量保证、法规培训

• Will attend internal Quality Assurance/Regulatory compliance audits and communicate results.

参加内部质量、法规审核并沟通结果

• Be involved or leads and implements the Lean philosophy – standardization and elimination of waste.

参与或领导并执行精益理念-标准化并减少浪费

• Fully authorized to “release” or “Reject” product, component, process, and so on according to QS requirements.

根据质量体系要求，全权处理“放行”或“判退”产品、部件、过程等。

• Ownership and reporting on all quality issues associated with suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated. Participate supplier change review and approval, be responsible for supplier related work in new project， e.g SPPAP.

在指派工作范围内负责与报告所有与供应商相关的质量问题。确保所有供应商相关质量问题被有效沟通。参与供应商变更的评审和批准,负责新项目中与供应商相关的质量工作,如供应商PPAP

• Act as a point of Contact for supplier Quality during External Audits and Internal Audits as required.

在应对组织内外部审核时，依据需求成为与供应商质量相关的联络窗口。

• Liaising with the Manufacturing and Engineering groups and Business Units, in assessing and addressing material quality issues. Track supplier quality performance measurement (KPI’s) and participate in supplier performance reviews.

协调生产部、工程部以及商务部门，共同协作解决原材料质量问题。监督供应商质量表现，并参与相关质量表现的评审。

• Other tasks assigned by supervisor

主管分配的其他任务

【任职要求】

REQUIRED SKILL SET岗位技能：

• Familiar with PPAP, FMEA, MSA, process control plan and SPC.

熟悉PPAP，FMEA，MSA，过程控制计划和SPC

• Must be able to analyze and resolve non-routine

product issues using independent judgment.

需能够独立判断并分析解决异常产品事件

• Excellent logical thinking

优秀的逻辑思维

• Effective interpersonal and trouble-shooting skills

有效的人际关系和解决问题的能力

• Good communication skills and training skills.

良好的沟通能力和培训能力。

• Basic PC skills & good operation skills of Excel

基本的PC技能和良好的Excel操作技能

• Quick learner

学习能力强

RELEVANT EXPERIENCE 经验要求：

• More than years in Quality Assurance or related functional area preferred

5年以上质量保证或相关职能领域经验优先

• Experience in GMP or ISO quality systems

有GMP或ISO质量体系经验

EDUCATION教育背景：

• College / B.S. in engineering or engineering related discipline.

工程或相关专业大专或本科学历。

Travel Percentage: None