职位描述
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Project Quality Engineer located in Suzhou SIP
Reporting to the Quality Manager, the PQE role involves..
What a typical day looks like:
• 确保产品质量和过程质量控制以满足客户要求。
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:
o 统计过程控制,质量检验和包装后检验
SPC Control, Quality Inspection and Post Pack Audit.
o 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.
o 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.
o 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.
o 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.
o 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.
o 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.
The experience we’re looking to add to our team:
• 大学专科或以上学历。
College or above
• 3年以上EMS行业 PQE/CQE相关工作经验
Minimum 5 years’ PQE/CQE working experience in EMS company
• 流利的中英文沟通表达能力
Fluent communication and presentation skills in English and Chinese
• 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.
• 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.
• 具备医疗器械质量管理经验优先考虑
Have experience or knowledge of medical device quality management system requirements is preferred.
What you’ll receive for the great work you provide:
• Social Insurance
• Life Insurance
• PTO