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 QA Assistant Manager-某丹麦医疗器械行业（猎头职位） |
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Belinda Chen
头衔: 海归少校
加入时间: 2010/03/01
文章: 71
海归分: 11790
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作者：Belinda Chen 在 海归招聘 发贴, 来自【海归网】 http://www.haiguinet.com
Purpose of the position:
1.Implement and maintain effective NCR, CA/PA system.
2.Implement and maintain effective supplier management and evaluation system.
3.Implement and maintain effective customer complaint handling system.
4.Conduct effective NEO training.
5.As Agile Change Analyst, perform workflow management in Agile, knowledge sharing and conduct in-house training as Agile expert.
6.Support Business System to improve the Agile workflow.
7.Coordinate and manage the calibration program for test and measuring equipments.
8.Oversee microbiology laboratory activities and clean room environment.
9.Assist the QA&RA Manager in all types of audits.
10.Monitor and ensure Quality ob<x>jectives and KPI’s are met.
11.Help promote and maintain an effective QMS system that is in compliance with ISO9001, ISO13485, 21CFR820, CE standards, Supplier Quality Agreement with AS and Chinese GMP.
12.Ensure compliance to regulatory and customer requirements of products and processes.
Responsibility in the position
1.Drive and monitor the progress of NCR and CA/PA until their closure. Make periodic trending and reporting.
2.Evaluate the effectiveness of NCR and CA/PA to prevent reoccurrence.
3.Conduct supplier management and evaluation and supplier and raw material classification.
4.Conduct complaint investigation, perform periodic trending and reporting.
5.Set up and conduct effective NEO training.
6.Analyse and review changes arisen from Agile as per Agile Change Analyst role.
7.Manage workflow in Agile and support Business System to improve the Agile workflow.
8.Conduct training as Agile expert.
9.Coordinate and manage the calibration program for test and measuring equipments.
10.Oversee microbiology laboratory activities and clean room environment.
11.Assist the QA&RA Manager in all types of audit/inspection activities, including the implementation and follow-up on all corrective actions.
12.Monitor and ensure Quality ob<x>jectives and KPI’s are met.
13.Identify existing and potential causes of nonconforming product, and processes and identify actions needed to correct and prevent occurrence.
14.Lead Quality Improvement Team.
15.Perform periodic data trend analysis and reporting to QA&RA Manager.
16.Assist QA&RA Manager to ensure Ambu Ltd's QMS is in compliance with ISO9001: 2008, ISO13485: 2003, 21 CFR 820, CE standards and Chinese GMP.
17.Assist QA&RA Manager to promote awareness of our QMS, Customer and Regulatory requirements in the daily work and live up to our four core TOTI values.
18.Ensure good adherence to Supplier Quality Agreement with AS per QP2001.
Requirement:
1.Bachelor’s Degree in any science discipline (minimum 8 years QA experience is preferred in the medical device or pharmaceutical fields). Microbiologist preferred.
2.Good knowledge and experience as QA in medical devices or pharmaceutical industries with exposure to US FDA and Chinese SFDA inspection.
3.High and excellent English speaking & writing skills.
4.Sound knowledge in ISO 9001, ISO 13485, 21 CFR 820 and Chinese GMP.
As target for C&B,
ba<x>se salary:15-20K/M.
如果有合适的朋友，请尽快投递简历，我们将第一时间和您取得联系，谢谢！
作者：Belinda Chen 在 海归招聘 发贴, 来自【海归网】 http://www.haiguinet.com
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 QA Assistant Manager-某丹麦医疗器械行业（猎头职位） -- Belinda Chen - (3315 Byte) 2012-10-29 周一, 15:21 (2966 reads)
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