Location: Shanghai, China
Position Type: Fixed-Term
Job Function: Quality
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:
-Responsible for quality document management system establish, maintain and improvement , to ensure compliance status to China regulation and BMX requirements
-Organize and coordinate the assigned work and provide
1.Safety, Health & Environment
-Ensure that all applicable Safety, Health & Environment requirements are compliant to group policy and local legal requirements.
2.QMS Establishment, maintain and improvement
-Set up principles and guide team for new QMS establishment
-Maintain document control process, including origin of internal or external, to ensure only valid and current version can be used for production;
-Maintain record control process to ensure a good record practice is implemented within the plant through routine training and monitoring;
-Responsible for internal audit implementation to ensure the system is consistenly complying to applicable standards/regulations;.
-Lead and coordinate external audits/inspections external audit/inspection, follow up of all audit related corrective action and make it close on-time.
-Responsible for supplier related quality management including new supplier qualifiaction, existing supplier quality issue handling, supplier audit program implementation and so on.
-Responsible for supplier related change management.
-Closely monitor regulation evolvement, implement gap analysis and follow up on mitigation plan implementation
-Implement QMS awareness training plant widely with the support from manager and BioMerieux Corp.
KNOWLEDGE, LANGUAGE AND EXPERIENCE:
1.Bachelor degree (equivalent) or above educational background, majoring in biology, chemistry, medicine or related working experience .
2.Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese.
3.2+ year above similar quality system management experience in Medical Device or Pharmaceutical Industry
4.Familiar with ISO9001& 13485, and other Medical Device or IVD related regulations
5.Skilled with Microsoft Word and Excel
6.Good Interpersonal skill and team player .