Business Improvements/业务改善

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

支持质量改进举措，例如过程和产品特性，从而得到持续性改善/成本改善。

• Conduct benchmarking to develop more effective inspection methods for improving quality.

执行基准，为了提高质量制定更有效的质量检验方法。

Compliance/Regulatory/合规/法规

• Support Quality Engineer to review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards.

支持质量工程师对当前产品和流程(包括操作或决策)是否符合标准进行查看/分析。

• Support Quality Engineer to conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

支持质量工程师进行定期的生产线审计以评估生产控制，如批次隔离。检查区域审计的结 果，确保纠正和预防措施是充分的。

• Support Quality Engineer to ensure the documentation and business process compliance, such as: handle the documentation approval process in PLM system, support training system maintenance, ECR process in SAP, dashboard creation/update, data processing, sample retention etc.

协助质量工程师确保文件和业务流程的合规性，例如：文件在PLM系统的批准流程、培训系统的维护、SAP系统中ECR的流程、报表创建或更新、数据处理、留样等等。

Product Quality, Control & Disposition and Performance Standards/产品质量，控制& 处置和性能标准

• Supports activities related to the Material Review Board.

协助MRB有关的活动。

• Support Quality Engineer to conduct actions of non-conformances, CAPAs and customer complaints.

协助质量工程师进行不合格、CAPAs和客户投诉的行动。

• Support Quality Engineer for material identification, material segregation, and classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.协助质量工程师进行物料标识，材料隔离，以及缺陷类型的分类，包括这些技术在日常生产中的成功应用。
• Support Quality Engineer to analyze/review effectiveness of preventive and corrective actions.

协助质量工程师分析/评审预防和纠正措施的有效性。

Production/Process Controls including Control Plans/生产/过程控制包括控制计划

• Support Quality Engineer to develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

协助质量工程师开发、说明和实施符合工艺/产品风险水平的合适的过程监控和控制方法。

• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

收集数据并执行各种分析/统计分析和解释，作为工艺改进和日常支持的一部分。

• Support Quality Engineer to develop, interpret and implement standard and non-standard sampling plans.

协助质量工程师开发、说明和实施标准和非标准的抽样计划。

• Support Quality Engineer to assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.

协助质量工程师评估测量工具的有效性、破坏性测试、非破坏性测试测量系统分析。

Risk Mitigation/风险缓解

• Support Quality Engineer to assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

根据产品分类、潜在缺陷类型、缺陷频率、严重程度、患者风险、过程能力、过程控制等，协助质量工程师评估风险缓解技术的需求。