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组件工程师/Component Engineer

刷新时间:2018-11-24

诺和诺德(中国)制药有限公司(天津)

11-17万

天津市 | 本科 | 3-5年

基本信息
工作地点:天津市 所属部门:耐用器械部
职位类别:电焊/铆焊工 招聘人数:1 人
汇报对象:组件经理
职位描述

Education Background: 教育背景

1.Master or Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, or Electronics Engineering.

2.Supplementary training in cGMP, component manufacturing and relevant standards

Professional Experience专业经验:

1.Minimum 5 years’ of experiences from a similar position.

2.Expert knowledge within injection molding process.in component manufacturing, validation and failure analysis.

3.Experience from working with Lean or Six sigma technologies and data analysis.

4.Experience of working in international environment.

5.Experience of supplier management.

6.Experience of project management skill

7.Expert knowledge within injection mold design and manufacturing (plastic only).

8.Expert knowledge within electronics HW/SW and failure analysis (electronics only).




Main Job Tase:主要工作职责

1.Non-conformity handling and scrap rate control

-Handle Non-conformity (NC, remark) related to responsible process and/or component as Non-conformity owner.

-Be task force owner to lead complex case and report progress to management.

-Support internal stakeholders about their investigation when need and give input as expected.

-Coordinate on-site sorting/rework if need.

-Complete committed corrective and preventive actions on time.

-Monitor component scrap rate in production and take preventive/corrective actions if necessary



2.Change control and validation

-Handle change related to responsible process and/or component as change owner.

-Support stakeholders’ change case when need and give input as expected.

-Cooperate with sourcing and supplier for capacity planning for new moulds or line validation.

-Responsible or support for validation at supplier based on supplier assessment result.

-Coordinate with internal stakeholders and supplier to align specifications, test plans and validation time schedule.

-Coordinate design review of new mould (plastic only).

-Manage the project both in daily work and Clarity system as project manager



3.Supplier Management –Technical related

-Coach suppliers for component’s technical requirements

-Contact with supplier to solve component technical and quality issues

-Make sure mold/tool spare parts quality and quantity for production safety stock

-Monitor the supplier on performance of issue handling, technical competence. eg. -OSS. Give input about supplier re-evaluation for technical related.

-Carry regular process confirmation to supplier manufacture process and maintain Supplier PC report.

-Observe improvement opportunity in supplier process and drive to implement.

-Evaluate supplier proposed change and review supplier change implementation.

-Review supplier reported nonconformity about investigation and actions.

-Maintain overview of tool/equipment (owned by NN) list in supplier.

-Handle purchase process with supplier for tool/equipment making , repair , maintenance and improvement.



3.Continuous Improvement (KAIZEN/VSM/DMAIC)

-Contribute improvement idea, lead to get aligned solution and follow up implementation. Eg, component quality improvement, component engineering procedure improvement, etc.





4.Others

-Be ready for the handled case for internal and external audit.

-Complete training course in time

-Data integrity compliance

-Maintain the documents in component team.

-Be responsible for the data updating of dept. KPI’s when necessary.



5.For SME assigned for component related process.Eg. certified deliveries, validation of external process, test production, mould management, etc

-Present process during Audit & inspection

-Present own process during audit/inspection

-Guide audit/inspection tour on shopfloor

-Coordinate with department fulfill audit/inspection request

-Support other engineers to answer question during audit & inspection

-Ensure global SOP & GMP requirements implementation

-Act as or supporting LDO, review key Global SOP and GMP requirements to ensure compliance

-Review/inputs to process report

-Gap analysis for the SOP/Report. Including DI.

-Coaching on compliance and Train engineers on process knowledge

-Identify compliance gaps in responsible process

-Coach other Engineers on compliance

-Share findings and new regulation requirements

-Inputs on NC/CR and Process Improvement

-Review NC/CR

-Coach others on how to write NC/CR

-Provide professional idea to continuous improvement projects

-Share best practice across sites

岗位要求:
学历要求:本科 工作经验:3-5年
年龄要求:不限 性别要求:不限
语言要求:普通话 专业要求:不限
企业信息
公司性质:其它 公司规模:1000-9999人
所属行业:制药/生物工程
企业介绍

在诺和诺德,我们致力于改变,通过改变来攻克糖尿病以及其他严重的慢性病。
诺和诺德拥有90多年的历史,是一家始终致力于创新的公司,是糖尿病领域的领先者。在糖尿病领域的经验也让我们可以为更多受其他慢性病困扰的人们提供服务,如:血友病、生长激素紊乱和肥胖症。
公司总部位于丹麦首都哥本哈根,在全球75个国家和地区拥有近4万名员工(数字截至2015年6月),产品行销180余个国家和地区。
诺和诺德(中国)制药有限公司是总部于1994年在华成立的全资子公司,注册地点座落于天津经济技术开发区。

企业信息

诺和诺德(中国)制药有限公司(天津)

制药/生物工程

1000-9999人

其它

天津经济技术开发区南海路99号

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