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台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
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廠商求才專線
台北 02-2913-8123
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

QE_Senior Quality Engineer

  • 全職

Position Summary
A mid senior level Quality Engineering personnel who applies scientific knowledge, engineering knowledge, and ingenuity to lead quality assignments related to medical device manufacturing. The candidate ensures consistent implementation and compliance to external regulations including, but not limited to FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 11608 & ISO 14971.
Responsibilities
 Represent QA in design review meetings to review all quality aspects of new products. Work with Design & Product Development Engineers to ensure quality considerations during design and concept stage.
 Assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – UFMEA, DFMEA, PFMEA.
 Review and coordinate with Validation for all test method and design validations.
 Provide input for product lifecycle through;
o Data collection and analysis
o Lead projects for continuous process improvement & review the level of control in manufacturing processes including the adequacy of current process limits.
o Reduction of reject levels
o Ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters
o Provide input on non-conformance events and Corrective Actions and Preventive Actions (CAPA).
o Develop and maintain quality measurement and inspection systems and quality indicating measurement methods and standards.
o Use statistical and problem-solving tools as part of delivering improvement opportunities.
Additional Responsibilities May Include:
 Material Review Board
 Change Request & review board
 Support scientific, complaint, and test failure investigations
 Lead Quality Plan development
 Directs the efforts of others such as engineers & technicians

工作條件

  • 接受身份: 上班族、外籍人士
  • 工作經歷: 五年以上
  • 學歷要求: 大學 碩士
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: Degree in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry.
     Experience in providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation, and Risk Management.
     Experienced with New Product Development.
     Demonstrate use of Quality tools/methodologies. Good knowledge of FDA, GxP, ISO 13485, and ISO 14971.
     Demonstrated and applied a broad knowledge of field of specialization through successful completion of moderately complex assignments.
     Good communication and interpersonal skills and demonstrates ability to participate in inter-departmental projects and resolve quality-related issues in a timely and effective manner.
     Has supervisory experience over technical staff, experience managing Engineers is preferred.
     ISO 11608 experience is added advantage.

福利制度

1. 保障年薪14個月 14 month annual guaranty salary
2. 年度員工健康檢查 Annual health check program
3. 員工團體保險(含意外險、防癌險、醫療險) Group insurance program
4. 週休二日 Two days off per week
5. 優於勞基法特休天數Better package in annual leave with pay
6. 彈性工作時間 Flexible working hours
7. 生育、婚喪補助金、旅遊津貼 Allowances of travel, birth, marriage and funeral grants etc.
8. 教育訓練(新進同仁訓練、OJT訓練、證照訓練、語文訓練、管理訓練等) Training programs (New employee orientation, OJT, licensing, language and management training etc.)
9. 多元開放的工作環境 Diverse and open working environment

更新日期:2019-07-09

應徵方式

  • 職務聯絡人: 人資部
  • 聯絡E-Mail: 未填寫 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年0%
5~10年100%
10年以上0%
學歷分佈
碩士及以上100%
大學0%
專科0%
高中0%
高中以下0%
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