Senior Manager, QARA

Summary Provides analysis, counsel, regulatory support, quality assurance, environment, health and safety, facility security and emergency response services, and regulatory and compliance technical training services to the organization. Individuals within this job family analyze regulatory aspects of operations activity, and recommend actions that maximize efficiencies and profits, ensure high product quality and provide the highest level of customer service. This job family is intended to accommodate

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   jobs whose accountabilities span two or more job families within the job group;

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   jobs that are not covered by a defined job family within the job group;

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   managerial roles spanning more than one family that are not broad enough in scope and impact to be assigned to the Business Unit/General Management job family within the Management job group. Job Description Serve as member of management as “Quality Management Representative” for the site; Oversee daily operations of the Quality team, ensuring timely and accurate inspection of incoming materials, final product release processes meet quality standard. Responsible for product quality monitoring, lead the non-conforming product control and provide quality tool training to drive quality improvement (e.g. 5WHY, Fishbone, etc). •Collaborate with global, cross-functional teams in driving and completing complaint investigations, adverse event reporting (e.g. NCMR, Complaints, etc), field corrective actions/recalls, and post launch product quality improvement, drive PPM reduction. •Accountable for implementing and maintaining QMS and quality processes aligned with ISO 9001, ISO 13485, China NMPA and support US FDA 21 CFR 820

, participate and support internal and external audits. •Establish and maintain site level KPI reporting and drive quality improvements, process improvement, optimize results to meet organizational Core Value Drivers (CVD) and Customer requirements. •Any agreed-to works by superiors. The essential requirements of the job include ○ Bachelor's degree in engineering with 9+ years experience, OR 本科学历并且有9年以上经验，或者 ○ Master’s degree with 7+ years experience 硕士学历并且有7年以上经验 Experience/understanding of IVD quality management system, post market process handling or CAPA processes are desirable ○熟悉IVD质量体系管理，后市场质量处理或者CAPA流程者优先 Extensive knowledge of medical device quality systems including but not limited to China GMP,21 CFR 820, ISO 14971 and ISO 13485. ○对医疗器械质量管理体系的广泛了解，包括但不限于中国国家药品管理局, FDA21 CFR 820, ISO 14971和 ISO 13485 ○ Ability of work in a highly matrixed and geographically diverse business environment preferred. 具备在高度矩阵化和地域分散的商业环境中工作的能力者优先考虑 Applies understanding of the business and how own area integrates with others to achieve departmental objectives ○应用对业务以及自己领域与他人的结合方式的了解实现部门目标 Travel, Motor Vehicle Record & Physical/Environment Requirements: 出差、机动车驾驶记录及身体/环境要求： ○ Ability to travel –5% travel, overnight, within territory or occasional international travel 可接受出差——约5%的出差频率，需过夜，在所负责区域内出差或偶尔进行国际出差 It would be a plus if you also possess previous experience in: 如果您还具备以下经验将更具优势： ○ Medical Device Industry 医疗器械行业经验 Professional designations not required but training and certification in quality or regulatory affairs are a plus (e.g. CQM, CQE, CQA, RAC, Six sigma, Lean) 不要求具备专业职称，但具备质量或法规相关培训及认证将优 先考虑（例如: CQM,CQE,CQA,RAC,六西格玛,精益管理）