職位描述
Main Purpose:
Leads the Quality System development and deployment
帶領品質體系的發展和資源配置。
Ensures products manufactured meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements.
確保產品生產需求符合技術規范的要求，產品開發和生產符合質量體系的要求。
Provides leadership and support for Customer Focused Quality, Quality Engineering and Quality System improvement initiatives.
帶領和協助顧客關注質量，品質工程師和質量體系的發展為顧客關注的質量、質量工程師和質量體系提升提供領導和支持。
Partner closely with partner site for overall product and system compliance.
與各合作伙伴密切聯系，以保證整個產品和體系的適應性。
Key Accountabilities:
Designs and deploys the quality system in the facilities
設置和部署公司的質量體系。
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.
帶領QA部門，確保質量體系的發展與符合FDA 質量體系法規要求，符合ISO9001，ISO13485/8，MDD，CMDR，日本R-RAL和其它質量要求。
Works closely with Site Leadership to enhance the overall effectiveness of quality system.
與各部門領導密切合作確保質量體系在公司內的有效性。
Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
成立質量項目和活動，保證產品和裝配按照相應的要求進行開發和生產。
Leads Manufacturing and Supplier Quality Engineering aspect to drive technically strong and data driven decision process.
帶領制造和供應商質量工程方面往技術趨動和數據趨動決策過程發展。
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.
提供引導和支持措施以確保有效的質量報告，質量體系、質量改進措施和顧客關注質量；監督管理質量體系政策和程序手冊。
Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
支持和發展鑒定、分析、改正和預防質量問題的體系。
Be part of CAPA board and drive related improvements in CAPA process.
作為CAPA團隊的一員，推動CAPA項目的發展。
Oversees returned product analysis and failure investigation activities for manufactured products.
負責監督退貨產品分析和生產故障調查活動。
Contributes quality expertise to product development and manufacturing transfers initiatives to ensure effective compliance to the Product Development Protocol and other applicable requirements.
用自己的經驗為產品的提高和生產轉化效率做貢獻，確保產品提高計劃和其他適用的要求能有效符合法規要求。
Manages, conducts and coordinates external (FDA, TUV, etc.) audits.
管理、引導和協助外部審核（包括FDA，TUV等）
Manages the design and manufacturing documentation and trace ability systems.
管理設計和生產的文件和追溯性系統。
Manages the QA Department including planning, budgeting, coaching, performance and salary reviews.
管理QA部門的計劃、預算、訓練、績效和薪酬評估。
Provides QA support, participate and collaborate in division related projects.
為各部門有關項目提供QA支持、參與或協作。
Works with local management team members in developing long and short-term business goals and strategies.
在發展長期、短期業務目標和戰略中，與當地管理團隊的成員合作。
Attributes:.
Sound business acumen
良好的商業頭腦
Highly developed people management skills
高度發達的人員管理能力
Self motivated, enthusiastic, positive
自我激勵，主動熱情
Professional, cooperative, and customer service focused attitude
專業，協作，關注于顧客服務的態度。
Takes initiative to complete work tasks and works well in a team environment
主動完成工作任務并能適應團隊工作環境
Leadership skills, team building and development
領導才能，團隊建設和發展能力
Ability to initiate and lead process improvements
發起和領導過程改進的能力。
Sensitivity to senior management’s needs and concerns
對管理的需求和關注點有高度敏感性。
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年醫藥管理、醫療器械或其它高度管制的制造業從業經驗。
Overall operational and financial acumen, Business and Project Management skills and experience a plus.
整體運營經驗及敏銳的財務意識，業務和項目管理技能和經驗者更佳。
Fluency in Quality System Regulation, MDD, and knowledge of Quality System Regulations and ISO.
熟悉質量體系法規，MDD，掌握質量體系法規和ISO知識。
Training in the following will be advantaged:
接受過以下培訓項目者更佳
ISO Standards
JSO 標準
Basic Statistics
基礎統計學
Quality Auditing
質量審核
Continuous Quality Im
