Job Title:  Validation / Quality Engineer

SUMMARY OF POSITION: 

职位概要：

The Validation Engineer will lead and participate in the development, implementation and adherence to validation procedures.

确认工程师将参与并领导确认程序的开发和实施，同时要遵守确认程序。

This position should comply with the new product development process, the project management system and the system of R & D policy.

此岗位遵守NPI新品开发流程、项目管理制度和研发制度。

ESSENTIAL FUNCTIONS: 

基本职能

• 新品开发

New product development：

• Initiates, controls and executes validation processes and procedures as required by the FDA,SFDA and other medical device regulatory systems

启动、控制并执行FDA、SFDA和其他医疗器械法规体系所要求的确认过程和程序

• Develop, document, and execute protocols and final reports (Installation Qualifications / Operational Qualification / Performance Qualification - IQ/OQ/PQ)

开发、书写并执行确认方案和最终报告（安装认证/操作认证/性能认证-IQ/OQ/PQ）

• Review and approve protocols and final reports (IQ/OQ/PQ)

评审和批准确认方案和最终报告(IQ/OQ/PQ)

• Represent the validation team in cross-functional meetings/projects

在多功能会议/项目中代表过程确认团队

• Coordinate and approve supplier protocols (IQ/OQ/PQ), working with Logistic Manager and responsible for manufacturing material supplier audit.

协调并批准供应商的确认方案(IQ/OQ/PQ)，与物料经理一起负责制造物料供应商的审核。

• 现场维护

Workshop management：

• Makes appropriate changes in manufacturing methods, processes and manufacturing process planning documentation based up validation strategy and result

基于确认策略和结果，在制造方法、加工和制造过程策划文件方面做恰当的变更

• Participates and supports Lean projects and process improvements

参与并支持Lean项目和过程改进

• Support manufacturing, engineering, and product development to implement new or changing processes.

支持生产、工程和产品开发去实施新的或者变更的过程

• Represent quality to audit and control material suppliers and distributors, work with them to solve material quality issues, material including raw material, manufacturing material and chemical.

代表质量方面审核材料供应商与分销商，与他们一起合作解决材料的问题。这里的材料包括原材料、制造材料和化学品。

• In charge of materials incoming inspection specs based on prints and industrial standards, verify materials test report for chemical and mechanical property (do not including materials size).

根据图纸与行业标准，负责进料检验规格，测试报告验证材料的化学性与机械性（不包括材料的尺寸）。

• Participate and/or leads cross-functional teams.

参与和/或领导多部门团队。

• Understand and follows company procedures and regulatory requirements.

理解并遵守公司的程序和法规要求

• Participates in and provides input to training on department and division procedures and policies.

参与部门和公司的程序及方针培训，并为培训提供信息输入

• Maintains professional working relationship with internal & external customer and support staff.

维护好与内外部客户和员工的工作关系

• Strong in authoring validation strategies, DOE (Design of Experiment), FMEA (Failure Mode Effect Analysis) risk assessments, process OQ protocols, process PQ protocols, technical completion reports, data analysis using Minitab, and SPC (Statistical Process Control).

在起草确认方针、DOE (Design of Experiment), FMEA (Failure Mode Effect Analysis)、OQ方案和PQ方案方面有很强的知识和技能

• Implement the tasked assigned by QMS

执行质量体系文件中要求的其他工作

• Implement the other tasks assigned by supervisor.

执行上级主管安排的其他工作

• Can work full day.

能出全勤

EDUCATION/EXPERIENCE: 

教育和经验：

• Bachelor’s degree or equivalent work experience.

学士学位或同等的工作经验

• Previous experience in Regulatory, Quality, Operations or R&D. 

在法规、质量、运营或开发方面有经验

• Previous validation experience preferred.

有确认经验者优先