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3 months ago
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Scope:
- Lead the supplier quality management of mass production instrument product and supplier development of new instrument product for Suzhou site of Beckman Coulter Laboratory System.
- Support the supplier quality management and the new supplier development globally for Beckman Coulter Group.
Responsibility:
- Â Maintain, review, and implement the procedure of supplier quality management.
- Responsible for handling the nonconformity of the incoming material, push the supplier initiate the root cause analysis and implement the effective corrective actions. Feedback, tracking and recording the related information on the SCAR.
- Responsible for the supplier change notification (SCN) on time evaluation and effective implementation.
- Responsible for developing and updating the incoming inspection guild line, ensure it with the latest status.
- Lead the supplier annual risk assessment work out the annual audit and visit plan, as well implement the audit, and visit activity as the schedule. Drive the supplier to continuously improve their quality management system.
- Lead the supplier performance assessment periodically, collect, evaluate, and report the supplier performance KPI,drive the supplier performance continuous improvement.
- Lead the supplier quality agreement change review and sign.
- Under the guidance, work together with the cross-function team (such as sourcing, tech Ops etc.) to development the new supplier, complete the new supplier qualification assessment and audit process.
- Under the guidance, work together with the supplier and Beckman cross function team to complete the new part/component development and approval process, including finishing the CQP, CQR, FAIR, Guild line and technical feasibility review.
- Under the guidance, support to complete the supplier quality management and development for the new project development and transfer project localization.
- Assist the internal QA to do the investigation for the customer complain and in-process nonconformity.
- Actively lead or participate in the Kaizen activities.
- Perform other tasks assigned by the supervisor.Â
Requirement:
- Bachelorâs degree or above, with 5+ yearsâ experience in quality field.
- Major in Engineering, such as Mechanical, electronic, etc.,
- With 3+yearsâ experience in supplier quality management in the industry of medical device, automotive, mechanical, electronic etc.
- Be familiar with the inspection tools, such as Gauge, Caliper, Micrometer, Projector, CMM etc.
- Be proficient in using the quality management and problem-solving tools, such as QC 7 tools, 5Whys ,8D, CAPA, SPC, CPK, MSA, FMEA, Control plan etc.
- With the knowledge of the technology and process, such as stamping, machining, sheet metal, welding, injection molding, surface treatment, SMT etc.
- Be familiar with QMS knowledge of ISO9001, ISO13485and etc., minimum with ISO9001 internal auditor certificate.
- Good problem identification, analysis and solving capability.
- Good English skill both in written and oral.
- Be familiar with the office tools including excel, word, PowerPoint etc.
- Good teamwork and communication skill.
- Efficient time management skills, strong self-driven and learning capability.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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