高级品质验证工程师/Senior Validation Engineer
爱尔兰西尼科有限公司宁波代表处
- 公司规模：少于50人
- 公司性质：外资(欧美)
- 公司行业：贸易/进出口 医疗设备/器械
职位信息
- 发布日期：2013-10-17
- 工作地点：宁波-鄞州区
- 招聘人数：1
- 工作经验：二年以上
- 学历要求：大专
- 语言要求：英语一般
普通话熟练 - 职位类别：医疗器械生产/质量管理 质量管理/测试工程师(QA/QC工程师)
职位描述
Responsibilities:
Requirements:
- Plan,perform,coordinate,analyze,maintain and follow-up overall validation activities in the company and associated sub-contractors.
- Maintain,update and distribute master validation plan after approval by management.
- Ensure implementation of all validation control plan including closing and report issuing.
- Coordinate and conduct process improvement project and new product development works/experiment.
- Maintain,monitor,update and ensure proper operations of calibration functions.
- Organize,perform and monitor vendors and service sub-contractor validation activities including Tooling,Sealing,Packaging,Transportation and Sterilization Validation.
- Defect analysis to improve/correct current systems and processes.Provide data and data analysis to monitor adherence to specifications.
- Organize,perform and monitor company Quality Systems and Processes audit.
- Candidate must possess Bachelor Degree in Chemistry,Chemical Engineering,Material Engineering,Material Science or Microbiology.
- At least 2 year(s) of working experience in Medical Device Manufacturing/Pharmaceutical Environment.
- Knowledge in FDA CFR 21,ISO 13485,etc.
- Knowledge in Statistical Process Control (SPC).
- Strong sense of commitment and the ability to work independently and under pressure.
公司介绍
Synecco are a specialist supply chain company focused on the medical device market headquartered in Galway, Ireland with manufacturing bases in China.
Founded in 2004, our resources in China, the US and Ireland work with client organizations providing integrated solutions from product design through to manufacturing and fulfillment.
爱尔兰西尼科有限公司是一家出口一次性无菌医疗器械的跨国贸易公司。总部在爱尔兰戈尔韦市，在宁波设有办事处。自2004年成立以来， 公司的业务不断拓展，由成立之初单纯的采购发展到现在的集设计、开发、制造于一身的综合性实体企业。经过近10年的发展，公司已经成功打入美国和欧洲市场，在这两个市场的一次性医疗器械领域占据了一席之地。随着公司规模的不断扩大，公司热切期待广大英才的加入。
Founded in 2004, our resources in China, the US and Ireland work with client organizations providing integrated solutions from product design through to manufacturing and fulfillment.
爱尔兰西尼科有限公司是一家出口一次性无菌医疗器械的跨国贸易公司。总部在爱尔兰戈尔韦市，在宁波设有办事处。自2004年成立以来， 公司的业务不断拓展，由成立之初单纯的采购发展到现在的集设计、开发、制造于一身的综合性实体企业。经过近10年的发展，公司已经成功打入美国和欧洲市场，在这两个市场的一次性医疗器械领域占据了一席之地。随着公司规模的不断扩大，公司热切期待广大英才的加入。