丁香人才 > 职位招聘 >医药研发/制药生产招聘 >药品生产/质量管理招聘 >上海药品生产/质量管理招聘 >黄浦区药品生产/质量管理招聘 >Senior Quality Engineer招聘

Senior Quality Engineer

宜曼达贸易(上海)有限公司 2016-12-06发布 2017-02-27截止
  • 学历要求: 本科
  • 英语要求: 熟练
  • 年龄要求: 不限
  • 专业要求: 生物工程,生物化...
  • 工作年限: 五年以上
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市黄浦区
  • 职称要求: 中级
  • 招聘人数: 1人

职位描述

Position Summary:
This position is responsible for Quality activities that measure, monitor, and improve Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, cFDA/FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.

Tasks and Responsibilities:
- Supports the distribution warehouse with focus on compliance with applicable China GMP Quality Management System, Quality System Regulations (QSR), ISO 13485 requirements and GDP Good Distribution Practice
- Ensures adequate control of nonconforming material.
- Manage investigations, disposition and CAPA processes.
- Develop, review and approve Quality System documents (e.g., Standard Operating Procedures, Forms, Specifications, Validations, etc.) to ensure compliance with applicable regulations (e.g., GMP, GDP, QSR, ISO, etc.)
- Monitor and analyze key metrics and drive improvements to distribution processes.
- Facilitate the training program required for distribution personnel.
- Ensure that records are complete, accurate and timely.
- Support development and executions of process verification and validation plans.
- Review and approve planned and unplanned changes/deviations.
- Collaborate with the Singapore Quality team to oversee, support, facilitate and/or drive the following areas:
- Change management activities
- Complaints, recall, field correctives
- Compliance Audits, inspections
- Suppliers / Service providers management
- Quality Management Review
- Other such duties that may be determined by Management.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

All About You
Requirements:
- Experience in Good Distribution Practice (GDP)
- Experience in supporting logistics/distribution environment
- Experience in cold storage and shipping validation highly desired.
- Six Sigma/Lean training;
- Experience in CAPA and Kaizen;
- Project management certification
- Working for a Medical Device or Medical Diagnostics company;
- ISO 13485 and ISO 9001 experience
- China FDA regulatory experience

Competencies:
- Ability to apply experience in meeting requirement of China Good Manufacturing Practice and ISO 13485 Standard.
- Experience in applying appropriate quality tools.
- Effective failure investigation, technical report writing, data mining, trend analysis, statistical analysis.
- Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
- May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc.
- May have experience with statistical analysis packages, eg, JMP, minitab.
- Must be detailed oriented, well organized and able to work independently and in teams.

Educational:
- Bachelor’s Degree in Engineering or Biological/Life Sciences
- More than 5 years of working experience in a regulated quality environment

Illumina is an Equal Opportunity Employer.

For interested applicants, please do the following:
1. Visit our Careers Page at http://www.illumina.com/company/careers/illumina-careers.html
2. Click 'Search Careers' and enter 4014BR in the 'Auto req ID' field to proceed with the application.
该单位 HR 近两周的应聘简历处理率: 20%

联系人: 宜曼达人事部

地    址:中国上海市淮海中路333号瑞安广场2210室

All About Us

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

lllumina has experienced phenomenal growth from $10 million in revenues in 2002 to approximately $1.9 billion in 2014. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review. As of December 2014, the company had a $26 billion market capitalization. ...详情

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