[成都] 美敦力医疗器械 招聘 quality system specialist

基本信息
企业名称：美敦力医疗器械
企业地址：成都市高新西区
公司行业：生物医药	公司规模：20-99人
公司类型：外商独资	职位类型：电脑/网络/IT类
职位名称：quality system specialist	招聘人数：1 人
职位要求
专业要求：	性别要求：不限
年龄要求：不限	学历要求：不限
英语要求：精通	电脑要求：不限
职位待遇
薪资待遇：面谈	福利待遇：
招聘要求

Main Purpose:
· Interprets government regulations as they apply to products, processes, practices and procedures to anticipate and integrate regulations changes into Chengdu.
· Coordinate and support the organization during external audits
· Coordinate answers to agencies and associated CAPA plans
· Lead the Quality System team to support Chengdu organization.
Key Accountabilities:
· Provide guidance and direction to Chengdu to ensure the compliance to Quality System Regulation and ISO Standards.
· Lead and provide coaching / guidance to the Quality System team to ensure the effectiveness of key quality system processes and continually improve these processes. Establish individual performance & development objectives / plan for Quality System team members.
· Participate in the CVG harmonization in close collaboration with all departments personnel to define adoption strategies
· Evaluate and perform assessment on the Product Change Request for manufacturing changes.
· Coordinate change approvals through Regulatory and Reliability.
· Interprets government regulations
o Understand regulation’s intent applying for Chengdu
o Anticipate regulation trend and knowledge to keep Chengdu 100% compliant
o Provide global analysis and propose integration strategy to Chengdu Compliance management
o Integrate new requirements and regulations changes into Chengdu QMS
o Update Chengdu documentation/procedures accordingly
o Provide coaching to business partners for Compliance topics
· External audit preparation / coordination
o Establish the preparation program involving all Chengdu partners
o Performs the coordination and preparation of external audits
o Thorough action plan progress check and raise any out of control situation
o Provide a clear picture to Chengdu management before inspection
o Ensure external audits logistics
o Participate to external audits/inspections as Chengdu Quality Compliance expert
o Support Chengdu auditees in providing the necessary documentation for the external auditors
· Agencies answers and associated Quality Systems
o Provide the necessary input / answer to regulatory agencies on Chengdu Quality System processes and work with Chengdu business partner to ensure timeliness and accuracy of information provided.
· Back-up
o In case of needs to be backed up : This role backup the Quality System Specialist and Senior Quality Engineer (Change Control)
o Is the back up if needed: This role is backed up by the Senior Principal Quality System Specialist.

公司信息：