Flex PQE Leader 

China, Jiangsu, Suzhou City 

536775824

Project Quality Engineer Leaderlocated inSuzhou SIP

Reporting to thePQE Leaderrole involves..

What a typical day looks like:

• Ensure product quality and process quality control to meet customer requirements.
• 就任何重大的质量问题与客户保持联系和合作。Work with customers for any major quality issue.
• 跟进客户审核和/或第三方审核。Follow up with customer audit and/or the 3rd party audit.
• 管理产品质量工程师和/或质量技术员和/或质量保证的执行.Manage product quality engineers and/or quality technicians and/or quality assurance to perform below actions:
• 统计过程控制，质量检验和包装后检验SPC Control, Quality Inspection and Post Pack Audit.
• 准备质量报告/文件，建立质量改进程序。Prepare quality reports/documents and establish quality improvement program.
• 与其他相关部门定期召开质量评审会议。Conduct regular quality review meetings with other relevant departments.
• 解决客户退货问题，定期回顾质量业绩。Resolve customer returns and review the quality performance regularly.
• 处理客户投诉并推动相关部门采取行动。Handle customer complaints and drive the relevant departments to take actions.
• 处理纠正措施以解决生产过程中可能导致质量或潜在质量问题的任何问题。Handle corrective actions to resolve any problems in the manufacturing process which can cause quality or potential quality problems.
• 制定质量检验和包装后检验指导书。Initiate working instructions of Quality Inspection and Post Pack Audit.

• College or above
• 8年以上质量工作经验，其中有2年的管理职位经验。Minimum 8 years’working experience, in which 2 years’experience in managerial position.
• 接受过质量工具和技术方面的培训，如统计过程控制、失效模式及影响分析、控制计划、纠正措施和预防措施和IPC-A-610标准。Be trained in quality tools and techniques such as SPC, FMEA, Control Plan, CAPA, and IPC-A-610.
• 具备医疗器械质量管理体系要求(例如：YY/T0287/ISO13485或同等标准)的经验或知识优先。Have experience or knowledge of medical device quality management system requirements (e.g. YY/T0287/ISO13485 or equivalent) is preferred.
• 有医疗质量体系、统计过程控制、技术管理等方面的培训经验.Be trained in medical quality system, statistical process control and technical management.
• 流利的英语口语表达能力 Fluent communication and presentation skills in English.

What you’ll receive for the great work you provide:

• Social Insurance
• Life Insurance

Required Skills:

Optional Skills: