职位描述
Main Purpose:
Leads the Quality System development and deployment
带领品质体系的发展和资源配置。
Ensures products manufactured meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements.
确保产品生产需求符合技术规范的要求，产品开发和生产符合质量体系的要求。
Provides leadership and support for Customer Focused Quality, Quality Engineering and Quality System improvement initiatives.
带领和协助顾客关注质量，品质工程师和质量体系的发展为顾客关注的质量、质量工程师和质量体系提升提供领导和支持。
Partner closely with partner site for overall product and system compliance.
与各合作伙伴密切联系，以保证整个产品和体系的适应性。
Key Accountabilities:
Designs and deploys the quality system in the facilities
设置和部署公司的质量体系。
Leads the QA function to ensure quality system development and compliance with FDA's Quality System Regulation, ISO 9001, ISO 13485/8, MDD, CMDR, Japan R-PAL and other quality requirements.
带领QA部门，确保质量体系的发展与符合FDA 质量体系法规要求，符合ISO9001，ISO13485/8，MDD，CMDR，日本R-RAL和其它质量要求。
Works closely with Site Leadership to enhance the overall effectiveness of quality system.
与各部门领导密切合作确保质量体系在公司内的有效性。
Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
成立质量项目和活动，保证产品和装配按照相应的要求进行开发和生产。
Leads Manufacturing and Supplier Quality Engineering aspect to drive technically strong and data driven decision process.
带领制造和供应商质量工程方面往技术趋动和数据趋动决策过程发展。
Leads and/or supports initiatives to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System Policy/Procedures Manual.
提供引导和支持措施以确保有效的质量报告，质量体系、质量改进措施和顾客关注质量；监督管理质量体系政策和程序手册。
Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
支持和发展鉴定、分析、改正和预防质量问题的体系。
Be part of CAPA board and drive related improvements in CAPA process.
作为CAPA团队的一员，推动CAPA项目的发展。
Oversees returned product analysis and failure investigation activities for manufactured products.
负责监督退货产品分析和生产故障调查活动。
Contributes quality expertise to product development and manufacturing transfers initiatives to ensure effective compliance to the Product Development Protocol and other applicable requirements.
用自己的经验为产品的提高和生产转化效率做贡献，确保产品提高计划和其他适用的要求能有效符合法规要求。
Manages, conducts and coordinates external (FDA, TUV, etc.) audits.
管理、引导和协助外部审核（包括FDA，TUV等）
Manages the design and manufacturing documentation and trace ability systems.
管理设计和生产的文件和追溯性系统。
Manages the QA Department including planning, budgeting, coaching, performance and salary reviews.
管理QA部门的计划、预算、训练、绩效和薪酬评估。
Provides QA support, participate and collaborate in division related projects.
为各部门有关项目提供QA支持、参与或协作。
Works with local management team members in developing long and short-term business goals and strategies.
在发展长期、短期业务目标和战略中，与当地管理团队的成员合作。
Attributes:.
Sound business acumen
良好的商业头脑
Highly developed people management skills
高度发达的人员管理能力
Self motivated, enthusiastic, positive
自我激励，主动热情
Professional, cooperative, and customer service focused attitude
专业，协作，关注于顾客服务的态度。
Takes initiative to complete work tasks and works well in a team environment
主动完成工作任务并能适应团队工作环境
Leadership skills, team building and development
领导才能，团队建设和发展能力
Ability to initiate and lead process improvements
发起和领导过程改进的能力。
Sensitivity to senior management’s needs and concerns
对管理的需求和关注点有高度敏感性。
Experience and Knowledge:
Minimum of 8 to 10 years management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry.
至少8-10年医药管理、医疗器械或其它高度管制的制造业从业经验。
Overall operational and financial acumen, Business and Project Management skills and experience a plus.
整体运营经验及敏锐的财务意识，业务和项目管理技能和经验者更佳。
Fluency in Quality System Regulation, MDD, and knowledge of Quality System Regulations and ISO.
熟悉质量体系法规，MDD，掌握质量体系法规和ISO知识。
Training in the following will be advantaged:
接受过以下培训项目者更佳
ISO Standards
JSO 标准
Basic Statistics
基础统计学
Quality Auditing
质量审核
Continuous Quality Im
