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QE_ Change Control Senior Engineer

  • 全職

Position Summary
A senior level Quality personnel who is responsible for managing plant-wide change control program. The candidate implements a risk control approach in handling change and ensure compliance to external regulations including, but not limited to FDA 21 CFR Part 820, ISO 13485 and Medical Device Directives (MDD).
Responsibilities
 Deploy and maintain best practices for Change Control through established processes, procedures and guidelines.
 Facilitate Change Request and Review Board (CRRB) meeting with governance committee to review all relevant change control request. Work with various stakeholders to ensure risk based approach is applied to mitigate risk associated with change.
 Responsible to deploy and maintain ERP system for Change Control. Ensure smooth transition from current system to Trackwise for Change Control, including dry run and validation of system.
 Supports the development of change control skills throughout the organization; provides mentoring and guidance change control owners and tracks plant-wide maturity level.
 Track monthly change implementation rate; includes periodic trending, notification and follow up for timely closure of CC’s.
 Works independently and with management for decision making on complex, highly visible, cross-functional projects.
 Ensure continuous process improvement by;
o Data collection and analysis
o Review the level of control in change control processes including the adequacy of current controls.
o Reduction of overdue change control items.
o Ensure there are appropriate procedure and process in place for identified criticality of change control items and define subsequent actions.
o Use statistical and problem-solving tools as part of delivering improvement opportunities.
Additional Responsibilities May Include:
 Material Review Board Participation
 Cross-site project involvement pertaining change control.
 Ensure validation activities are aligned to CRRB decision.
 Involve in Quality Plan development
 Lead and coach other personnel in Change Control and Validation department.

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 Quality department, experience in Quality Systems, Change Control, Process Validation, and Risk Management is added advantage.
     Demonstrate use of Quality tools/methodologies. Good knowledge of FDA, GxP, ISO 13485, and MDD.
     Demonstrated and applied a broad knowledge of field of specialization through successful completion of moderately complex assignments.
     Good communication and interpersonal skills, English proficiency is a must – candidate works closely with Sweden and US offices.
     Demonstrate 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0%
大學100%
專科0%
高中0%
高中以下0%
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