職位描述
We at Siemens Healthineers? are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.
What are my responsibilities?
1. Develop, establish, maintain and optimize a consistent global QMS together with the process owner, including required certifications based on internal and external quality/regulatory related requirements and in alignment with the Siemens Process work fulfilled.
2. Develop and deliver training to build quality awareness of SCM.
3. Support the quality improvement projects initiated by SCM to provide knowledge of quality tools.
4. Review and approve change request and concession to ensure the quality requirements were met.
5. Control and ensure effective implementation the process of NCP. If necessary , use authority to refuse production.
6. Follow up the correction of process deviation, process quality improvement, initiate data analysis and corrective & preventive s if necessary.
7. Ensure implementation and controlling of quality gates on manufacturing process.
8. Monitor in process quality performance, initiate data analysis and take corrective & preventive s if necessary.
9. Responsible to check product version and package, release DHR acceptance etc. related certificate.
10. Coordinate to solve non-conforming materials from supplier, feedback to SQE and monitor effectiveness.
11. Reduce the NCP and NC cost through quality improvement projects.
12. Monitor quality cost before delivery, initiate data analysis and take corrective & preventive s if necessary.
What do I need to qualify for this job?
1. Procedure & standards understanding (ISO9001, ISO13485 etc.)
2. Problem solving techniques such as 8D
3. Fluent in English (spoken and written)
4. Experience in medical device related products is preferred
5. Statistical methods and data analysis capability
6. Bachelor degree or junior college with 3 years working experience