1. 岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

 确保从供应商采购的产品和服务符合生物梅里埃的质量标准。

Ensure products and services purchased from suppliers meet the quality standards of bioMerieux.

 与采购、供应链、质量控制、工业化、制造和工程部门紧密合作，执行供应商质量程序。

Work closely with Procurement, Supply Chain, QC, Industrialization, Manufacturing and Engineering in the execution of the supplier quality program.

 提供质量业务支持供应商纠正措施报告 (SCAR) 管理、供应商变更控制、供应商管理和供应商资质认证，以确保符合 NMPA 和其他监管要求。

Provide quality support in the areas of Supplier Corrective Action Request (SCAR) management, supplier change control, supplier management, and supplier qualification to ensure compliance with the NMPA and other regulatory requirements.

 履行维持有效的质量体系并确保产品质量的基本职责。

Perform essential duties that maintain an effective quality system and ensure product quality.

2. 主要职责 / MAIN ACCOUNTABILITIES

1）Safety, Health & Environment /安全，健康和安全

 确保符合总部EHS方针、本地法规以及ISO14000的需求。

Ensure compliance with global EHS policy, local regulation and ISO 14000 requirements.

 学习、掌握并执行国家、政府职能部门、地方的HSE法律法规要求、标准，履行法规要求的HSE责任和义务。

Learn, master and follow HSE laws, regulations, requirements and standards of the country, functional government departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.

   严格遵守公司HSE规章制度，服从公司的HSE管理，并执行本岗位的HSE管理要求，承诺“不伤害自己、不伤害他人、不被他人伤害，保护他人不受伤害“的四不伤害员工职责。 对被赋予的工作活动做好危害辨识、风险评估、应急预案并确保执行安全操作规范。有责任及时汇报HSE隐患及事故。

Strictly comply with HSE rules and regulations and implement the HSE management requirements of this position. Promise to follow the requirement "do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm". Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely.

2）Quality Management System/质量管理体系

 确保遵守国家药品监督管理局相关法规、ISO 13485 标准、公司质量程序、和其他适用行业标准，以支持完成公司业务目标。

Support the company’s business goal of ensuring compliance with NMPA regulations, ISO 13485 standard, company quality procedures and other industry standards applicable.

 维持使用工厂的供应商质量体系要素的合规性（例如：供应商审核、供应商质量管理、供应商变更控制）

Maintain compliance of Supplier Quality System elements applicable to the Site (e.g. Supplier Audits, Supplier Quality Management, Supplier Change Control)

 支持工厂、集团质量以及监管当局的良好生产规范和ISO 13485质量体系等检查和审核活动，回答有关供应商质量控制和评估的问询。。

Supports site, corporate and competent authority quality system inspections and audit activities of GMP and ISO 13485 etc. including communication with competent authority and follow up mitigate actions, answer inquiries regarding the control and assessment of supplier quality.

3）Supplier Quality Management/供应商质量管理

 与采购紧密合作对供应商进行管理和监督，确保供应商提供的材料、组分、部件、服务等满足梅里埃质量标准。

Tightly working with procurement to management and supervision of suppliers, to make sure provided material, components, parts, services meet quality standards of bioMerieux.

 协助供应商的评估、批准和不批准，包括与采购合作对供应商的等级评估，并支持持续改进项目。

Assist with the evaluation, Approval and Disapproval of suppliers, including collaboration with the procurement on supplier leveling and Support continuous improvement projects.

 在适用情况下，起草并和供应商签署质量协议。

Draft and sign Supplier Quality Agreements with supplier when applicable.

 制定和管理供应商审核计划，包括：审核计划、安排审核时间、执行审核、撰写审核报告以及按需跟进纠正措施。

Create and manage the supplier audit program including audit plan, scheduling, audit execution, writing audit report and follow up on corrective actions as needed.

 供应商指导委员会会议和业务评审中担任主要供应商质量联络人，提供信息和指标。

Act as Principle Supply Quality contact at Supplier Steering Committee meetings and Business Reviews providing information and metrics.

 与采购一起维持供应商关系并管理供应商关键指标，持续监控供应商绩效，并在适当的供应商指导委员会(SSC) 会议上汇报质量指标数据。

Manage relationships and key metrics for suppliers with procurement, keep monitoring supplier performance and report Quality Indicator data during appropriate Supplier Steering Committee meetings.

 如果因供应商问题导致不合格，则发出供应商纠正措施报告 (SCAR)，跟踪回复、批准供应商调查、核实纠正措施并确保其有效性。

Issue Supplier Corrective Action Request (SCAR) if non-conformance arises due to supplier issue, tracks responses, approve investigations, verify corrective actions and ensure effectiveness.

 参与变更审查委员会，作为供应商质量评审人和专家，参与供应商相关的变更控制管理活动。

Act as Change Review Board participant and Supplier Quality reviewer and SME for change control management activities related to supply change.

 负责供应商相关的变更管理，通过跟踪、评估和协调（必要时）因供应商变更而进行的技术评估、图纸/文档更新和 SAP 更新来管理供应商变更通知。

Responsible for supplier-related change management. Manage supplier change notifications by tracking, evaluating, and coordinating (when necessary) technical assessments, drawing/document updates and SAP updates due to supplier changes.

Supplier Quality Management/供应商质量管理

 与采购紧密合作对供应商进行管理和监督，确保供应商提供的材料、组分、部件、服务等满足梅里埃质量标准。

Tightly working with procurement to management and supervision of suppliers, to make sure provided material, components, parts, services meet quality standards of bioMerieux.

 协助供应商的评估、批准和不批准，包括与采购合作对供应商的等级评估，并支持持续改进项目。

Assist with the evaluation, Approval and Disapproval of suppliers, including collaboration with the procurement on supplier leveling and Support continuous improvement projects.

 在适用情况下，起草并和供应商签署质量协议。

Draft and sign Supplier Quality Agreements with supplier when applicable.

 制定和管理供应商审核计划，包括：审核计划、安排审核时间、执行审核、撰写审核报告以及按需跟进纠正措施。

Create and manage the supplier audit program including audit plan, scheduling, audit execution, writing audit report and follow up on corrective actions as needed.

 供应商指导委员会会议和业务评审中担任主要供应商质量联络人，提供信息和指标。

Act as Principle Supply Quality contact at Supplier Steering Committee meetings and Business Reviews providing information and metrics.

 与采购一起维持供应商关系并管理供应商关键指标，持续监控供应商绩效，并在适当的供应商指导委员会(SSC) 会议上汇报质量指标数据。

Manage relationships and key metrics for suppliers with procurement, keep monitoring supplier performance and report Quality Indicator data during appropriate Supplier Steering Committee meetings.

 如果因供应商问题导致不合格，则发出供应商纠正措施报告 (SCAR)，跟踪回复、批准供应商调查、核实纠正措施并确保其有效性。

Issue Supplier Corrective Action Request (SCAR) if non-conformance arises due to supplier issue, tracks responses, approve investigations, verify corrective actions and ensure effectiveness.

 参与变更审查委员会，作为供应商质量评审人和专家，参与供应商相关的变更控制管理活动。

Act as Change Review Board participant and Supplier Quality reviewer and SME for change control management activities related to supply change.

 负责供应商相关的变更管理，通过跟踪、评估和协调（必要时）因供应商变更而进行的技术评估、图纸/文档更新和 SAP 更新来管理供应商变更通知。

Responsible for supplier-related change management. Manage supplier change notifications by tracking, evaluating, and coordinating (when necessary) technical assessments, drawing/document updates and SAP updates due to supplier changes.

 根据需要提供供应商质量指标（例如：每周、每月、每季度的报告和管理评审会议）。

Provide supplier quality metrics as needed for company (e.g. weekly, monthly, quarterly report and QSMR).

 依据工作需要出差。

Business trips per work requirement.

4）Project Management/项目管理

 支持持续改进项目。例如：物料采购本地化。

Support continuous improvement projects. E.g Material localization procurement.

 发展专业知识，应用公司政策和程序来解决各种问题。

Developing professional expertise, applying company policies and procedures to resolve a variety of issues.

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

 本科及以上学历，机械、电子、材料、化学、生物医学工程等相关理工科专业，需要有至少3年以上的医疗器械行业供应商质量管理经验。

Bachelor’s degree or above, Mechanical, Electronic, Materials, Chemical, Biomedical Engineering and other related science and engineering majors. Candidates should have at least 3 years of experience in quality management for medical device suppliers.

 本科及以上学历，机械、电子、材料、化学、生物医学工程等相关理工科专业，需要有至少3年以上的医疗器械行业供应商质量管理经验。

Bachelor’s degree or above, Mechanical, Electronic, Materials, Chemical, Biomedical Engineering and other related science and engineering majors. Candidates should have at least 3 years of experience in quality management for medical device suppliers.

 熟悉机加工、注塑、电子装配、生物原料、关键化学试剂等生产工艺，能对标准和图纸解读，了解工艺失效分析方法者优先。

Familiarity with production processes such as machining, injection molding, electronic assembly, biological raw materials, and key chemical reagents; ability to interpret standards and drawings; and understanding of process failure analysis methodology are preferred.

 熟悉ISO9001、ISO 13485、 ISO 14971, GMP等医疗器械及生物安全等相关的法规规范，有ISO13485内审员资质，质量审核员或供应商质量专业人员资质者优先。

Be familiar with relative medical device regulation and bio-security and other codes, such as ISO 9001, ISO 13485, ISO 14971 and GMP, candidates with ISO13485 internal auditor certificate, CQA or CSQP certificate will be given priority.

 有良好的逻辑思维，团队合作和沟通能力。

Possesses strong logical thinking, teamwork, and communication skills.

 语言技能：英语和中文听、说、读、写熟练，有欧美外资企业工作经验者优先。

Language skills: Proficient in Listening, Speaking, Reading and Writing of both English & Chinese, applicants with working experience in European and American foreign-funded enterprises will be given priority.

 能熟练操作Word和Excel等办公软件，熟悉SAP系统者优先。

Proficient in operating office software such as Word and Excel, candidates familiar with SAP will be given priority.