苏州招聘

职位描述：
This position is posted for Morgan International Trading ( Shanghai ) Co.,Ltd. Address: No. 108 Tong Sheng Road, Suzhou.

A fully qualified, and competent Project engineer (QUALITY) is required to support the successful transfer and implementation of all technology, process, manufacturing operations and management systems pertaining to the implantable feedthrough production process (post ceramic operations) already established at Morgan New Bedford, USA site to China as part of a phased project to develop a ‘best-in-class’ feedthrough workshop at the proposed site in China. This Quality engineer will be part of a team of project engineers & solely dedicated to the successful implementation of the QMS requirements of the medical feedthrough workshop, reporting directly to the FT Project Manager and with a dotted-line to the Technology & Process Transfer Manager/lead at New Bedford, USA.

Job Responsibility:
1. Support the transfer of QA/QC specific knowledge & documentation from New Bedford, US to the new site and translation to local language; generation of quality related SOPs/OMSs/VSOPs etc.
2. Responsible for the transfer and implementation of all medical FT production process parameters; SPC and QC procedures + generation of standard documentations
3. Detailed outline of the procedures relating to incoming material inspection and release forms prior to processing; generation of QC/QA standard documents used for the recording of all QC in-process measurements, metrology and final tests/validation
4. Responsible for the setup & management of new site QMS system in line with ISO 9001 standard and guidance from NB
5. Responsible for the installation, set up and commissioning of all measurement/metrology & testing equipment and development of regular calibration schedule/plan to ensure accuracy of data generated
6. Responsible for the maintenance and revision of all QC/QA documentation and release to the production area – in line with agreed document control procedures
7. Must be able to implement all quality requirements as dictated by ISO 13485 for the FT workshop
8. Responsible for reporting and troubleshooting quality related issues during commissioning and developing the procedure for resolving and closing quality issues during normal operation – in line with NB procedure
9. Responsible for development of training plan & assessment of future QC engineers + QC team development

Job Qualification:
- Engineering degree (Process Engineering or associated discipline background) – Bachelors or Masters level
- Operations expertise/background preferred - Is experienced in using quality improvement tools such as Total Quality Management (TQM), Six sigma, capable of using Minitab & other statistical analysis tools
- Worked in Manufacturing/Production environment (Medical Equipment/Device manufacturing company desired)
- Knowledge of quality systems, standards and regulations
- Experienced in planning and running control experiments and must understand sample size, measurements and terminology. Hands on experience in quality assurance
- Minimum 8 years’ work experience
- CQE certified
- QMS & ISO 9001 awareness
- Have knowledge of CFDA Regulation
- Have knowledge of ISO 13485 system & requirements
- Good communication skills that focus on simplicity and clarity of presentation, both written and oral (desired)
- Highly proficient in the use of MS Office, MS Projects & MS PowerPoint.
- Must have good understanding of quality audits and know how to do one. Experienced in continuous improvement & problem solving techniques (KAIZEN), must be capable to analyze and understand data produced by statistical process control (SPC).
- CET-4 or above, very fluent spoken and written English. (desired)

  摩根国际贸易（上海）有限公司是摩根先进材料下属的碳和技术陶瓷事业部的一个全资子公司。摩根先进材料是一家全球领先的先进材料公司，致力于凭借全球领先的技术，以真正的差异化产品和服务在有吸引力的市场中建立可持续的竞争优势，包含热能产品事业部、碳和技术陶瓷事业部两大全球事业部。
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