Quality Engineer

Your Job

• To ensure all validation and quality control activities are compliant with the regulatory requirement, customer requirement, and internal QMS requirement in new product introduction phase.

在新品导入过程中，确保所有的验证行动和质量管理符合法规要求，客户要求，及内部质量管理体系要求。

• To ensure all purchased material and supplier management process are compliant with the regulatory requirement, customer requirement, and internal QMS requirement.

确保所有的采购物料和供应商管理流程符合法规要求，客户要求，及内部质量管理体系要求。

• To ensure all material, products and process quality can meet Product Specification.

确保所有的物料、产品和过程的质量满足产品规格。

• Core team member of a project during project launch phase.

项目导入过程中的核心小组成员。

What You Will Do

1.Create and maintain PPAP packages-APQP, PFMA, control plan, SPC, MSA, etc., and submit to customer for approval. Include supplier PPAP manage until to get final approval.

创建和维护PPAP文件包，包括APQP, FMEA, 控制计划，统计过程控制，测量系统分析等，并递交给客户批准。也负责供应商PPAP直到最终批准。

2.Manage the supplier assessments and audits and supplier quality monitor and evaluate periodically.

管理供应商评估及审核，及定期对供应商质量监控。

3.Create all quality plan and inspection instruction for purchased material, components, and products, including sampling plan, inspection method, AQL, acceptance criterion and perform the training to the responsible person.

建立采购物料,部件及产品的质量计划或检验规范，包括抽样计划，检验方法，接收水平和接收准则并培训至负责人 。

4.Create the SPC method for process control and perform the training to the responsible person.

创建过程统计控制方法，并培训至负责人。

5.Create all the record templates for the product inspection activities.

为产品检验活动创建所需的记录模板。

6.Conduct the validation protocol creation and execution.

主导验证方案的撰写及运行。

7.Change management, include supplier and internal, as a supplier contact window for change and track until closed.

内外部变更管理，作为供应商变更的联络窗口并追踪至关闭。

8.Monitor the supplier and internal quality performance during incoming and in-process, and follow non-conformance process handling when quality issue happens, drive root cause analysis and CA or PA.

在进料及过程中监控质量表现含内部及供应商的物料，当有质量问题出现时依不合格品处理流程处理，并带领团队进行原因调查及纠正预防措施的实施。

9.Customer compliant handing, lead root cause analysis and implement improve action and prevent action, finish 8D or CAPA report and review with customer.

客户抱怨的处理，领导根本原因的分析和实施改善动作和预防动作，完成8D报告和CAPA报告。

10.Support plant continuous improvement/scrap reduction project, include work with supplier chain team to develop the CI with suppliers.

支持公司持续改进及降低不良, 也包括供应商端的持续改善。

11.Follow EHS related laws, regulations, and company's EHS related management regulations, timely report potential risk, and propose safety improvement suggestions; For management position, be responsible for EHS management of the department/team.

遵守环境和职业健康安全相关法律法规，遵守公司环境和职业健康安全相关管理规定，及时上报身边安全隐患，并提出安全改进建议; 若为管理岗位，需负责本部门、团队的环境和职业健康安全管理。

12.Other duties as assigned by supervisor.

其他由主管指派的任务。

Who You Are (Basic Qualifications)

4-5 bulleted, objective, non-comparable requirements are recommended

Required必需： Bachelor degree or College degree /本科或大专

Preferred优先：Mater degree. Major in Mechanical Manufacture and Production Engineering Technology.

硕士学历，主修机械制造和生产工程技术。

Required必需:

• Knowledge in ISO13485 and QSR 820.

良好的ISO13485和QSR 820质量管理体系知识

• Good communication skills, fluent English both in written and oral, strong problem-solving skills, the knowledge of FMEA/SPC/QC 7 tools/8D.

出色的沟通技巧，流利的英语书面和口语沟通能力，较强的问题解决能力，良好的FMEA、SPC、QC7 tools 、8D的知识。

• Good analytic senses

良好的分析思维

• Good knowledge of molding or assembly

良好注塑或组装知识

Preferred优先：

• Knowledge in GMP/GDP/FDA/NMPA/MDR requirements.

良好的GMP/GDP知识，及FDA/NMPA/MDR的法规理解

• Willing to travel frequently.

愿意频繁出差

Required必需:

• 3-5 years working experience in medical device or pharmaceutical manufacturer or supplier management experience.

3-5年医疗器械或制药公司工作经验或供应商管理工作经验。

• Experienced in validation process of new project.

丰富的新项目过程验证经验。

• Individually handle new project quality plan set up and validation protocol creation.

能独立运行新专案，创建质量计划并主导验证方案的建立。

What Will Put You Ahead

Preferred优先：

• Be familiar with the Molding process and high-automation assembly process.

熟悉注塑及自动化组装过程。

• Experience in Software validation

软件验证经验

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.