Manufacturing Engineer

Suzhou - China

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

KEY RESPONSIBILITIES / DUTIES主要职责:

Provides Engineering knowledge support to a process project or other function. Knows and applies fundamental Engineering and Quality Management System concepts practices and procedures.

提供工程知识支持工艺开发项目及其他部门熟知质量管理系统理念实践和流程

Ensure quality of process and product as defined in appropriate OS and Material specifications.

保证工艺产品质量满足操作系统及材料规格要求

Ensure GMPs and system safety.

保证GMP 执行及系统安全

Lead PFMEA Control Plan SOP and PPAP generation associated with product transfers and scale ups.

领导过程失效模式及分析控制计划标准作业程序生产批准流程生成有关产品转移及扩展

Support capital acquisition activity from specifying equipment contract negotiation Installation and validation.

支持固定资产的投资设备选型合同谈判安装验证

Provide training for manufacturing team members.

为生产团队提供培训

Interface with Materials Science Design and Quality Assurance departments to provide customer with a quality product in a timely manner.

配合材料技术设计质量保证部门及时给客户提供高质量产品

Communicate and participate in system and process troubleshooting with support team members and with external agents.

支持团队及外部代理商沟通和参与系统及工艺问题解决

Lead and participate cross functional and cross divisional process improvement initiatives.

领导及参加跨职能跨部门的工艺改善活动

Identify quantify and implement opportunities to reduce cost of goods

识别量化和实施改善机会减少产品成本

Provide engineering support to the Advanced Operations (AO) team for new Product and new process introduction.

新产品新工艺的引入提供工程技术支持AO团队

Conduct Process validation for products and processes; VP IQ OQ PQ and associated documentation.

策划实施对产品及工艺进行验证安装验证工艺验证的相关文件

Conduct Gauge R&R studies for products and new processes.

对新产品新工艺策化实施量具量测系统分析

Application and development of statistical tools for use in driving continuous improvement projects.

应用和开发统计工具的使用推动持续改善项目

Manage non-conformities (NC) and Corrective/Preventive Actions (CAPA) with the QA departments

和质量部门处理NCCAPA

All other duties as assigned.

执行其他被安排的任务

SUPERVISORY RESPONSIBILITIES管理职责:

May lead one or more engineering technicians and/or manufacturing engineers.

能领导一个或更多技术员和工程师

REQUIRED SKILL SET岗位技能

Business understanding of operations and there impacts essential.

理解运营业务及影响要素

High level of PC Skills required.

高水平的电脑应用能力

Flexibility essential.

必要灵活性

Strong communication skills with both internal and external stakeholders.

对内外部客户有很强的沟通技能

Self-starter with demonstrated efficient work methods analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

具有高效的分析解决问题的能力可以在快节奏中处理多个工作

The individual should enjoy working in a dynamic and results motivated team environment.

喜欢在有动力自我驱动的环境中工作

Green Belt 6 Sigma qualifications required

6 Sigma 绿带资格认证

Black Belt 6 Sigma an advantage.

6 Sigma 黑带更好

Ability to effectively work cross-functionally with A.O Quality etc.

有效的和跨职能部门和AO质量等部门合作

Fluent English writing and speaking

英文写说流利

Project Management skills

项目管理技能

RELEVANT EXPERIENCE

经验要求

Has 0- 2 years experience in a manufacturing environment.

在制造环境中有02年的工作经验

Experience in an FDA regulated or regulated industry beneficial.

有FDA 法规及监管规范经验

Experience in a six sigma and Lean Manufacturing environment with proven improvement results.

有6 sigma及精益生产及改善项目的经验

EDUCATION

教育背景

B.S or master in Engineering preferred

机械工程本科或硕士学历优先考虑

Travel Percentage: None

Work Flexibility: OnsiteKEY RESPONSIBILITIES / DUTIES主要职责:Provides Engineering knowledge support to a process project or other function. Knows and applies fundamental Engineering and Quality Management System concepts practices and procedures.提供工程知识支持工艺开发项目及其他部门熟知质量管理系统理念实践和流程Ensure quality of proce...