Process Engineer
- 江苏省苏州市
- 长期
- 全职
- Recommend, design, select machinery, tools, jigs, and fixtures required to machining the products.
- 建议、设计、选择加工产品所需的机械设备、刀具、工装与夹具。
- Work with other Manufacturing Engineers to maintain the item master, product routings and bills of material in the MRP system.
- 与其他制造工程师合作，在MRP系统中维护条款主文件、产品工艺路径和物料清单
- Deliver necessary training for workshop employees;
- 为车间员工提供必要的培训;
- Responsible for continuous improvement initiatives, such as projects to improve quality, cost, delivery and efficiency.
- 负责持续改进举措，例如改进质量、成本、交付和效率的项目
- Use PE principles to improve processes and reduce non-value-added waste and activities. (Including process FMEA, Gauge R&R, Predictive Indicator and use of statistical techniques).
- 使用PE原则来改进流程并减少非附加值的浪费和活动。 （包括过程FMEA，Gauge R＆R，预
- 测指标和统计技术的使用）。
- Participate to identify capital spend and budget requirements.
- 参与确定资本支出和预算需求。
- Participate or lead layout design / implementation for facility and equipment.
- 参与或领导设施和设备的布局设计/实施
- Support R&D on new products development and quality system implementation.
- 支持新产品开发和质量体系实施
- Understand the Quality philosophy based on FDA QSRs, ISO 9000 and SFDA requirements.
- 理解基于FDA QSR，ISO 9000和SFDA要求的质量理念
- Understand, compile and control non-conformance data and product tractability.
- 理解、编制和控制非符合项数据和产品易追溯性
- Responsible for creating and maintaining manufacturing documentation for equipment and processes.
- 负责创建和维护设备和流程的制造文件
- Responsible for compiling the validation/verification protocols and completing studies by creating finished reports.
- 负责编制验证/确认协议，并创建完成的报告完成研究。
- Understand special processes requirements are plus, such as Sterilization, Cleaning, Packaging, FPI etc.
- 理解特殊工艺要求是加成，如灭菌，清洁，包装，FPI等...
- Understand computer software validation requirements.
- 理解计算机软件验证要求
- Perform all job duties in full accordance with:
- 按照以下要求履行工作职责：
- - The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect
- critical Business Information.
- 基于强生对信息、资产保护、密码保密以及关键业务信息的政策
- - All J&J policies and local regulations.
- 所有强生的政策和当地法规
- - The policies of the Health Care and Environmental programs.
- 健康和环境方案的政策
- - The code of conduct policies.
- 行为准则政策
- Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc.
- 对所有审核