Senior Quality Engineer (上海)
15K~25K/月
更新:2024-04-30
浏览:{{clickNum}}人
投递:{{supplementary.job_apply_num}}人
{{hasFav===true?'已收藏':'收藏'}}
您尚未登录,点击登录后可获取企业联系方式
职位联系方式
仅对求职者会员开放
您还没有简历,创建简历后可查看企业联系方式
您还没有投递简历,投递简历后可查看企业联系方式
企业未开启查看联系方式,请直接投递简历
企业未开启查看联系方式
您已投递简历,请等待企业联系
Area of Responsibilities: Evaluates techniques and recommends changes. Work with engineering, R&D, production, quality, regulatory affairs, and other departments to define and establish procedures and quality standards. Participates in the planning, development and transference of products and changes to materials, machinery or processes. Ensures compliance of project activities to appropriate regulations and standards (FDA, CFDA, ISO, EN). And establish and optimize the internal procedure according to regulations and standards. Improves products through implementation of quality management specifications, procedures, test methods and measurement systems. May handle investigation of customer complaints as it relates to supplied components and ensures implementation of CAPAs to prevent re-occurrence. Approves the resolution of complex quality issues be means of root cause(s) identification. Directs the development of product & process validation protocols examines and approves the validations final summary reports. Focuses and guides the quality continual improvement efforts to attain total customer satisfaction and regulatory compliance. Work within and monitor the corrective action system, MRB Reviews, correct implementation of engineering changes and material or process deviations - Conduct process and product audits to ensure conformance to specifications and company approved procedures - Provide direction and guidance to the inspection personnel to ensure timely product/process inspections - Act as liaison with several product quality and safety testing and certification organizations. Coordinates with the materials review group, quality, material, purchasing, engineering, etc, to determine the disposal of non-conforming materials, initiate the request of corrective actions and follow up on the resolution of problems to eliminate or minimize incoming inspections. Participates in external and internal quality product/process/supplier/system audits. Minimizes customer complaints due to product quality through effective corrective action systems. Initiates and directs corrective actions to problems relating to product or process quality. Communicates essential Management Review data to senior leadership such as SCAR, NCR, CAPA and complaint trending and analysis. Supports the improvement, implementation, maintenance and measurement of the effectiveness of the quality system including inspection systems, policies and procedures, testing measurements, non-conformances, corrective actions, customer complaints, training and internal audits. Prepares and supports validation protocols of equipment and processes (IQ, OQ, PQ, MVP y TMV). Coordinates compliance of raw material inspection procedures and processes to assure quality requirements. Directly addresses failure analyses, non-conformances, corrective actions, and customer complaints. Initiates and directs Non-Conformances Reports and Corrective Actions to problems relating to product or process quality. Collaborates in continuous improvement programs using DBS tools. Person Specification ü Minimum 3- 8 years’ experience at engineering level. ü Knowledge of MS Office, Minitab, Quality Systems, Regulations, Solidworks, GD&T and Outlook. ü Medical device Quality Engineering experience – Preferred ü Experience with statistic tools (SPC, DOE, ANOVA). – Required ü Experience with FMEA, Control Plans, FAI, GR&R’s. – Required ü Experience with process/component validation and inspection methods. – Required ü Experience with root-cause analysis, corrective actions and customer complaints.- Required ü Experience managing multiple projects – Preferred ü Professional Certifications: ASQ (i.e CQA, CQE, CRE), Six Sigma, Lean Manufacturing. – Preferred ü Knowledge of ISO13485– Strongly preffered ü Advanced degree - Preferred ü Strong written and verbal skills in both English and Mandarin – Required
扫描关注更多招聘信息
安卓开发工程师 2024-04-30
15K~21K/月 浦东新区 本科 2年
光学系统工程师 (职位编号:01) 2024-04-30
25K~30K/月 浦东新区 硕士 2年
生命科学工艺开发 - 下游(丹纳赫) 2024-04-30
12K~20K/月 浦东新区 本科 2年
前端开发工程师 2024-04-30
15K~20K/月 浦东新区 本科 3-5年
Senior System Engineer (上海) 2024-04-30
20K~30K/月 浦东新区 本科 5-10年
C++软件开发工程师 2024-04-30
14K~20K/月 浦东新区 本科 2年
资深前端开发工程师 2024-04-30
20K~40K/月 浦东新区 本科 3-5年
软件开发实习生 2024-04-30
5K~7K/月 浦东新区 本科 1年
10471-产品专员-上海市 2024-04-30
13K~22K/月 徐汇区 本科 2年
生命科学工艺开发 - 上游(丹纳赫) 2024-04-30
面议 浦东新区 本科 2年
{{supplementary.watch_percent}}
简历查看率
{{supplementary.last_login_time}}
登录时间
{{supplementary.reg_duration}}
入驻时长
科学仪器行业
其它 1000-9999人
使用微信扫一扫
此职位即刻传送到手机
最近登录时间:2022/06/07 15:45:13
最近登录IP:192.168.51.* []
以上资料仅供参考,请求职者 规避求职风险