Main Purpose:
•Interprets regulations and standards as they apply to products, processes and procedures to anticipate and integrate changes into Chengdu Quality System.
•Coordinate and support the organization during external audits and the response.
•Assist to guide and direct Chengdu team to ensure the compliance to Quality System Regulation and ISO Standards.
•Assist to support the forming of QBwM (Quality Begins with Me) Culture at Chengdu site.

Key Accountabilities:
•Collaborate with Business Group SMEs to ensure Chengdu Quality System align with Business Group requirements.
•Assist team to ensure the effectiveness of key quality system processes and continually improve these processes.
•uate and perform assessment on the Product Change Request for manufacturing changes.
•Coordinate change approvals through Regulatory and Reliability.
•Interprets government regulations
oUnderstand regulation’s intent applying for Chengdu.
oAnticipate regulation trend and knowledge to keep Chengdu 100% compliant.
oProvide analysis and propose integration strategy to Chengdu Compliance management.
oIntegrate new requirements and regulations changes into Chengdu QMS.
oProvide coaching to business partners for Compliance topics.
•External audit preparation / coordination
oEstablish the preparation program involving all Chengdu partners
oPerforms the coordination and preparation of external audits
oThorough plan progress check and raise any out of control situation
oProvide a clear picture to Chengdu management before inspection
oParticipate in external audits/inspections as Chengdu Quality Compliance expert
oSupport Chengdu auditees in providing the necessary documentation for the external auditors
•Agencies answers associated Quality Systems
oProvide 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.
•Lead the site QMS training program and Process Assessment program.
•Support the CAPA process and Management Review activities.
•Be responsible for the document change control, training program and document control of Chengdu.

Attributes:
•Takes initiative and demonstrates leadership
•Task oriented and result driven
•Flexibility and adaptability
•Analytical skills
•Persuasive, open minded and active listener
•Teamwork skills
•Tenacity and engagement, patience and perseverance

Experience and Knowledge:
•Minimum 4-6 years’ experience of Quality System management and exposed to ISO, PMDA, FDA and other regulatory agency inspections
•Admin or user experience of electronic management systems for documents, training or CAPA is an asset
•Knowledge on MES or ERP system is an asset
•Experience in a medical device company, pharmaceutical manufacturing company or equivalent will be an advantage
•Change management and GMP & GDP experience
•Fluent in English language both in written and oral


Qualifications:
•Bachelor’s Degree in science or Engineering or equivalent
•With ISO13484 internal auditor certification or lead auditor certification preferred
•Flexible for meetings accommodate U.S. And EU working time

关于美敦力
美敦力是全球最大的医疗科技集团公司，在全球范围内向140多个国家提供创新型医疗产品。作为一家全球医疗解决方案提供商，美敦力致力于为慢性疾病患者提供终身治疗方案--减轻病痛、恢复健康、延长寿命。

目前，平均每1秒钟，全球就有两位病人受益于美敦力的产品或疗法。我们非常注重业务领域的技术革新，每年将收入的10%用于新技术和新产品的开发，保证了我们医疗行业先锋的地位。

美敦力共有超过8.5万名员工，在全球160多个国家或地区开展业务运营。2014财年营收277亿美元。2015福布斯全球2000强企业排名中，美敦力位于第249位；2015年美国最佳雇主500强企业中，美敦力位于第232位。

美敦力在成都
2014年7月，美敦力与成都市政府签署战略合作协议，并于次月成立其全资子公司：美敦力医疗器械（成都）有限公司。该公司位于成都高新区，注册资本贰仟伍佰万美元。

美敦力在成都将设立肾护理业务中心、建设新型便携式肾透析设备生产线。该项目是美敦力全球首个创新血液透析系统开发生产项目，是美敦力本土化创新战略的又一坚实里程碑。美敦力落户成都，成为成都第一家在蓉跨国医疗器械企业制造基地，意味着成都生物医药领域招商的重大突破，也是成都参与全球高端医疗健康产业国际合作的重要举措。

美敦力成都的每位员工都被同一个目标鼓舞：帮助全世界的患者减轻病痛、恢复健康、延长寿命。在不久的将来，打上“成都制造”标签的美敦力创新血透系统产品将销往全球各地，为全世界的终末期肾病患者提供服务。

员工是美敦力最珍贵的资源，更是美敦力的家人。美敦力强调对员工的回报。“确认公司雇员的个人价值，建立优越的雇佣制度，使雇员获得对工作的满足感，使其职业有保障，并能够分享公司的成果。”是美敦力的使命之一。

“减轻病痛、恢复健康、延长寿命”是美敦力 不变的使命。我们希望能为每一个拥有相同使命感的优秀人才提供机会。我们也相信美敦力为每一位员工提供的不仅仅是拥有一份使命感，更包括了无限的个人成长及职业发展机会和家的温暖！

美敦力成都正在快速蓬勃发展。请抓住这前所未有的时机，递交求职申请。与我们一起，享有多轨道的发展模式，有竞争力的薪酬福利。

加入美敦力，为生命接力！
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