QC Engineer – IQC

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QC Engineer – IQC Jobs in Shanghai, Shanghai, China at 梅里埃营养科学（中国）

Title: QC Engineer – IQC

Company: 梅里埃营养科学（中国）

Location: Shanghai, Shanghai, China

该职位来源于猎聘 2. 主要职责 / MAIN ACCOUNTABILITIES 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. Quality and Regulation/质量和法规  确保遵守国家药品监督管理局相关法规、ISO 13485 标准、公司总部和工厂内部程序文件和规范、以及其他适用行业规范。 Ensure compliance with relevant regulations of the National Medical Products Administration, ISO 13485 standards, internal procedures and specifications of the company headquarters and factories, and other applicable industry standards. Quality Control /质量控制  撰写质量控制程序以适应产品技术要求、中国强制性标准和法规，确保所有检测方法的可靠、准确并标准化。

Written quality control procedures to adapt to product technical requirements, Chinese mandatory standards and regulations, ensure the reliability, accuracy and standardization of all testing methods, and possess the ability to provide internal quality control training and knowledge sharing.  解读蓝图要求并确认符合规范，包括适用的检验设备、抽样原理、数据分析、审核以及各种仪器的操作原理和功能。 Interpreting blueprint requirements and confirming conformance to specifications appropriate inspection equipment, principles of sampling, data analysis, auditing, and the theory of operation and function of the various instruments.

 负责确保质量控制检验方法和检验设备的可操作性，主导检验方法的标准化和改进。 Responsible for ensuring that QC Inspection Methods are accurate and executable. Lead in the standardization and advancement of inspection methods.  确保使用的检验设备和质量控制工具均有效的维护、校准和验证。 Ensure that all inspection equipment and quality control tools used are effectively maintained, calibrated, and verified.  培训质量控制工程师和技术员，协调和统筹质量控制团队的工作。 Train QC Engineers and Technicians, coordinate and manage the work of the quality control team.  按需及时执行各类质量控制检查，包括组件和原材料的首件检验、来料检验、过程检验和最终检验，确保符合规范。。 Conduct wide variety of QC inspections in a timely manner as needed, including First Article Inspection, Incoming Inspection of components and raw materials, In-Process Inspection and the Final Inspection, ensuring conformance to specification.  基于需求，支持仪器的型式检验和/或其他关于物料、检验软件和产品验证/确认的工作。 Based on requirements, support type testing of instruments, and/or other verification/validation work related to materials, inspection software, and products.  执行必要的质量控制过程检验和评审，以支持仪器制造。评估子组件、成品设备以及组装和测试流程是否符合记录的要求。 Perform Quality Control in-process inspections & review necessary to support Instrument Manufacturing. Assesses subassemblies, finished devices, and the assembly & test processes for conformance to documented requirements.  对于发现的不合格物料，包括生成不合格报告，该报告需要对异常情况进行技术上准确的描述。 For materials found to be nonconforming, generation of nonconforming reports, requiring a technically accurate description of the anomalies.  负责确保不合格物料、生产线废弃物料和已清除物料得到隔离和标识，包括不合格物料的处置符合所有必要的现场和监管要求。 Responsible for ensuring nonconforming, Line Throw Off, and Purged material is segregated and labeled including the disposition of non-conforming materials meet all necessary site and regulatory requirements.  支持因供应商提供组件造成的故障调查：配合调查产品、子组件、工艺和组件的故障，以确定根本原因和趋势。将这些信息传达给内部人员和供应商质量工程师，以确保供应商了解情况并采取纠正措施。 Support Component Failure Investigation cause of supplier issue: Cooperate with investigate failures of product, subassembly, processes and components to identify root causes and trends. Communicate this information internally and to supplier quality engineers to ensure supply awareness and corrective action.  检验和故障调查过程的要求是对需求的解读，以及运用谨慎的判断来确定是否符合要求。需要具备批判性的合理判断力和一致的决策能力。 Inherent in the process of inspection and failure investigation is the interpretation of requirements, and the need to use careful judgment to determine compliance. Critical sound judgment, and consistent decision-making are required.  按需调查不合格项，并独立处理，或与技术人员和/或工程师协作，诊断并解决问题。负责亲自跟进纠正措施，或确保由相关工程师处理每个问题。 Investigate nonconformances, and either independently address them, or interface with technicians and/or engineers to diagnose and remedy the problem as needed. Is responsible to either follow through the course of corrective action themselves or ensure that a cognizant engineer is addressing each issue.  Maintain thorough knowledge of the transactions in the ERP system (SAP) for movement of materials. 熟练掌握ERP系统（SAP）中物料转移相关的指令操作。  始终透彻理解所有规范、要求和程序，并就每一项的持续改进提供意见。 Maintains thorough understanding of all specifications, requirements, and procedures and provides input regarding the continuous improvement of each.  支持变更控制，作为质量控制专家协助评估和识别措施并执行。有能力做质量变更控制负责人，负责质量控制相关的质量变更的发起、协调和跟踪。 Support change control, assisting in the evaluation and identification of measures and their implementation as a quality control expert. Capable of serving as the person in charge of quality change control, responsible for initiating, coordinating, and tracking quality-related changes.  负责监视和测量质量控制检验数据，并做分析统计和趋势分析，输出内部质量的质量指标以支持持续改进。 Responsible for monitoring and measuring quality control inspection data, performing statistical analysis and trend analysis, and outputting quality indicators to support continuous improvement. 职位要求： 3. 知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE  本科及以上学历，电子，软件、仪器等有源医疗器械相关专业，需要有至少5年以上的电子和医疗器械软件加工行业研发和/或生产企业质量控制相关工作经验，如有3年以上有源医疗器械相关经验者优先。 Bachelor’s degree or above in electrical, software, instrument or other active medical device-related fields. Applicants should have at least 5 years of experience in R&D and/or quality control in the electronics and medical device software manufacturing industry. Priority will be given to candidates with more than 3 years of experience in active medical devices.  需有质量控制团队的统筹和工作安排经验，如有带人经验者优先。 Must have experience in coordinating and arranging work for a quality control team. Obtain experience in leading teams will be given preference.  需具备较强的计算机技能，包括熟练使用Microsoft Office办公软件（Excel、Word等）。熟悉质量记录控制系统（Trackwise）和SAP系统者优先。 Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.). Familiar with the Trackwise quality record control system and SAP system will be given preference.  具备阅读和理解复杂蓝图的专业能力，熟悉几何尺寸和公差 (GD&T) 者优先考虑。 Expert ability to read and interpret complex blueprints, a plus would be the knowledge of Geometric Dimensioning & Tolerancing (GD&T).  熟练使用精密机械测量仪器、坐标测量机、光学比较仪、显微镜、测量示波器、仪表和其他各种电气测试设备。 Expert ability to use precision mechanical measuring instruments, coordinate measuring machine, optical comparators, microscopes, measure scopes, meters and other various electrical test equipment.  熟悉印刷电路板和线束等电子元器件的加工和检测知识和技术，有IPC-A-610H和IPC-A-620E认证证书者优先。 Familiar with the processing, manufacturing, and testing knowledge and technology of electronic components like printed circuit boards and wire harnesses; those with IPC-A-610H and IPC-A-620E certifications will be given priority.  熟悉并理解国内外相关的法规和行业标准， 特别是GB 4793 《测量、控制和实验室用电气设备安全技术规范》及其参考规范中对于安全规范的要求和检验方法。 Be familiar with and understand relevant domestic and international regulations and industry standards, especially the safety requirements and testing methods in GB 4793 ＜Safety technical specification for electrical equipment for measurement, control and laboratory use＞ and its reference standards.  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 English and Chinese listening, speaking, reading and writing; those with work experience in foreign-invested enterprises in Europe and America are preferred.  熟悉中国医疗器械注册质量管理体系法规、中国医疗器械生产监督管理条例及其下所有附属法规和ISO 13485质量管理体系要求，有ISO13485内审员证书者优先。 Familiarity with China’s medical device registration quality management system regulations, China’s medical device production supervision and management regulations and all its subordinate regulations, and ISO 13485 quality management system requirements; those with ISO 13485 internal auditor certificates will be given priority.  需具备较强的书面和口头沟通能力，能够与公司各层级人员有效互动。同时，需具备较强的分析能力，能够进行决策和解决问题。能够作为质量控制代表参与生产、工程、研发和质量等部门的团队协作 Requires strong interpersonal written and verbal skills to interact with all levels of the organization. Also requires a solid analytical approach to decision making and problem solving. Ability to be a QC representative in groups of peers from production, engineering, R&D, and quality.  能够在有限的监督下工作，并按时完成项目。 Ability to work with limited supervision and to complete projects in a timely fashion.