Job Deion:
Product/process validation:产品/过程确认
1 Lead new product/process validation, including DQ, IQ, OQ and PQ stages.
主导新产品及新工艺确认,包括DQ, IQ, OQ 和 PQ各阶段
2 Ridation for validated product or process every 5 years.
每5年对已确认的产品及工艺进行在确认.
3 Lead a cross-function team to finish control plan, FMEA, MA and test plan for new product/process.
领导跨职能小组完成新产品/新工艺控制计划,潜在实效模式,测量协议和测试计划
4 Yearly baseline checking for validated product/process.
每年对已确认的产品及工艺进行基线参数检查
Customer complaint :客户投诉
1 As a contact window of customer complaint and forward related information to internal team.
客户投诉的联系窗口,并及时把相关信息传达给内部
2 Handling customer complaints, including root cause analyses and implementation of corrective s and preventive s
处理客户投诉,包括根本原因分析和纠正预防措施的执行
3 Finish customer complaint report.
完成客户投诉报告
Continuous improvement activities:持续改善活动
1 Review internal deviation reports issued by production team or technical team, and give comments.
评审生产部/技术部发起的测试方案和测试报告,并给出建议
2 Send internal deviation report to customer if need and close it.
如果需要,把内部偏差报告发给客户并关闭
3 Follow up corrective and preventive s for internal deviation.
跟踪内部偏差的纠正预防措施
4 Approve new WI or updated WI issued by production team or technical team.
批准生产/技术部新的或更新的作业指导书
5 Review test protocol and test report for process improvement.
评审过程改进的测试方案
6 Review and close CAPA project if need.
如果需要评审并关闭CAPA项目
Daily work:日常工作
1 Approve new route card from production.
批准生产工单
2 Defective parts judgment and sign the limit sample for internal team.
内部不良品判断及签署限度样件
3 Uniform inspection method between production and QC team.
统一生产及QC的检验标准
4 Participate internal audit, customer audit and 3rd party audit, and follow up corrective and preventive s if need.
参加内审,客户审核及第三方审核,跟踪纠正预防措施(如果需要)
5 products partner and coordinator for internal deviation.
做内部偏差的产品合作人及协调员
6 Other work assigned by quality assurance supervisor or quality manager.
其它主管或经理指派的工作
Qualification：
1 Good English skills in both writing and oral.
英语读写技能良好
2 Skills in “Good documentation practice”.
有良好文件操作规范的经验
3 Internal audit experience.
有内审经验
4 Have worked with ISO13485, minimum ISO9001 or TS16949.
有ISO13485经验，至少懂得ISO9001 或 TS16949
5 Have problem solving skills as “8D”, "5 Why","DMAIC" or similar.
有“8D”, "5 Why","DMAIC"相关技能
6 Knowledge about "control plan","FMEA","MSA" etc.
了解控制计划,潜在实效模式,测量系统分析
7 Have worked with "change control", "CAPA" or "validation".
有变更控制，CAPA或确认经验

医乐世（天津）医疗器械技术有限公司，成立于2010年1月，坐落于西青开发区赛达国际工业城，是瑞典ELOS AB公司在中国投资的全资子公司，公司主要生产医疗器械和精密机械零部件等，拥有高精密加工工艺和严格的质量控制体系。在瑞典、丹麦、美国均设有子公司。目前员工人数120人。

作为一家来自瑞典的公司，北欧的管理风格，开放的办公环境，和谐的人文氛围，公司不断提高客户满意的同时，也在不断完善员工各项福利。公司提供市区班车、午餐、年度健康体检，为员工上六险一金，按照当地法规要求支付防暑降温费、取暖费、中夜班津贴等。全员全年享有12天以上年假并逐年增加（上限20天），节日红包、生日红包、健康年度体检等福利。
希望有识之士加盟，公司会为其提供良好的培训机会及工作环境，让我们一起开创美好的未来。

请详见公司地理位置图或使用百度地图、谷歌地图搜索“医乐世”了解公司具体位置。
面试者可公交换乘708路到赛达国际工业城内“灵北制药站”下车，或从大寺镇打车前往。