Quality Engineer

Business Improvements 业务改进

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

支持质量改进活动,对产品 / 过程进行持续改进和成本改善。

§ Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

评估和分析质量工具及项目的有效性,比如 PDCA ,六西格玛,改善,精益技术和 / 或其他改进工具。

§ Conduct benchmarking to develop more effective methods for improving quality .

通过标杆管理开发更有效的质量管理方法提升质量。

§ Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

开发合适的质量管理方法应用于质量工程和质量合规的发展,运用在新产品导入和产品生命周期管理。

Compliance/Regulatory 合规管理

§ Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.

评估和分析现有产品和制程是否合规,比如 QSRs , ISO13485 等法规要求

§ Champions compliance to applicable Global Regulations and standards (e.g.

QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

支持工厂的内外部审核,遵守适用的法规和标准 ( 例如 QSRs, ISO, EN 和 MDD) 要求。

§ 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.

执行周期审核评估生产现场是否合规。审阅区域审核的结果确保纠正和预防措施有效。

New Product/Process Introduction 新产品 / 制程导入

§ Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.

协调研发和其他的跨部门合作确保相关领域质量管理可控。比如设计管理,风险管理,研发失效的调查 / 纠正等方面。 /

§ Supports new product introduction as part of design transfer.

支持新产品导入业务活动,作为研发项目转移的-部分。

Product Quality, Control & Disposition and Performance Standards 产品质量控制处理和执行

§ Supports activities related to the Material Review Board.

支持材料审核相关业务活动

§ Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.

Escalation of quality issues as appropriate.

执行 NC , CAPA 和客户投诉的调查分析,审阅和批准。

§ Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of...