该职位来源于猎聘  Maintain supplier files and electronic databases as assigned (5%)  Responsible for new supplier qualification. Conduct supplier audits as required by business objectives and established schedule. Write audit reports and follow-up on corrective actions that result from supplier audits till closure. Audit focus on supplier quality management system and technical capability to meet S&N product standard. (30%)  Conduct technical assessment to evaluate whether supplier have stable and capable process capability to manufacture good quality parts to meet/exceed smith-nephew standards. (5%)  Issue Supplier Corrective action requests to improve supplier quality. (15%)  Define verification and validation requirement for new sourced parts. (5%)  Go to supplier site to solve problem which includes but not limit on quality, delivery, cost and etc. (5%)  Supplier kaizen workshops, main goal is to continuously improve the Suppliers Quality level, reducing both escaping defects and associated Cost of Quality, according the relevant metrics in place. (5%)  Use and train supplier about quality tools such PFEMA, Control Plan, MSA, 5 why, 8D and etc to control process, drive root cause and corrective actions. Use statistical techniques to perform complex data analysis from various data sources, identify the trend, and gap, drive supplier on continuous improvement. (10%)  Establishes and maintains supplier quality risk management and

Requirements

License/certification: Certified ISO 13485 Quality Auditor; 6 Sigma GB ; 6 Sigma BB background definitely a plus

Competencies: Have a certain deep knowledge about GMP and GDP requirement. Quality control and problem solving related to Machining and secondary process, laser marking, labeling and final cleaning. Experience in performing IQ/OQ/PQ. Hands-on experience in the application of root-cause and problem solving techniques involving supplier-based processes (5 why, 8D report). Good knowledge of GD&T, Quality tools SPC, PCS, PFEMA, Control Plan, MSA, etc. Have experience to lead different functions to complete tasks such as supplier qualification, validation, problem solving, continuous improvement. Good oral and written English. Good communication skill.

Experience: At least 5-year quality management work in Multi-national or Local medical device company, Working knowledge of QMS Standards required (ISO13485 or equivalent). Experience in performing supplier audits and assessing supplier capabilities.