職位描述
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
企業介紹
關于美敦力
美敦力是全球最大的醫療科技集團公司，在全球范圍內向140多個國家提供創新型醫療產品。作為一家全球醫療解決方案提供商，美敦力致力于為慢性疾病患者提供終身治療方案--減輕病痛、恢復健康、延長壽命。
目前，平均每1秒鐘，全球就有兩位病人受益于美敦力的產品或療法。我們非常注重業務領域的技術革新，每年將收入的10%用于新技術和新產品的開發，保證了我們醫療行業先鋒的地位。
美敦力共有超過8.5萬名員工，在全球160多個國家或地區開展業務運營。2014財年營收277億美元。2015福布斯全球2000強企業排名中，美敦力位于第249位；2015年美國最佳雇主500強企業中，美敦力位于第232位。
美敦力在成都
2014年7月，美敦力與成都市政府簽署戰略合作協議，并于次月成立其全資子公司：美敦力醫療器械（成都）有限公司。該公司位于成都高新區，注冊資本貳仟伍佰萬美元。
美敦力在成都將設立腎護理業務中心、建設新型便攜式腎透析設備生產線。該項目是美敦力全球首個創新血液透析系統開發生產項目，是美敦力本土化創新戰略的又一堅實里程碑。美敦力落戶成都，成為成都第一家在蓉跨國醫療器械企業制造基地，意味著成都生物醫藥領域招商的重大突破，也是成都參與全球高端醫療健康產業國際合作的重要舉措。
美敦力成都的每位員工都被同一個目標鼓舞：幫助全世界的患者減輕病痛、恢復健康、延長壽命。在不久的將來，打上“成都制造”標簽的美敦力創新血透系統產品將銷往全球各地，為全世界的終末期腎病患者提供服務。
員工是美敦力最珍貴的資源，更是美敦力的家人。美敦力強調對員工的回報?！按_認公司雇員的個人價值，建立優越的雇傭制度，使雇員獲得對工作的滿足感，使其職業有保障，并能夠分享公司的成果?！笔敲蓝亓Φ氖姑?。
“減輕病痛、恢復健康、延長壽命”是美敦力 不變的使命。我們希望能為每一個擁有相同使命感的優秀人才提供機會。我們也相信美敦力為每一位員工提供的不僅僅是擁有一份使命感，更包括了無限的個人成長及職業發展機會和家的溫暖！
美敦力成都正在快速蓬勃發展。請抓住這前所未有的時機，遞交求職申請。與我們一起，享有多軌道的發展模式，有競爭力的薪酬福利。
加入美敦力，為生命接力！
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