職位描述
Main Purpose:
Leads the Quality System development and deployment
帶領(lǐng)品質(zhì)體系的發(fā)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(chǎn)品生產(chǎn)需求符合技術(shù)規(guī)范的要求，產(chǎn)品開發(fā)和生產(chǎn)符合質(zhì)量體系的要求。
Provides leadership and support for Customer Focused Quality, Quality Engineering and Quality System improvement initiatives.
帶領(lǐng)和協(xié)助顧客關(guān)注質(zhì)量，品質(zhì)工程師和質(zhì)量體系的發(fā)展為顧客關(guān)注的質(zhì)量、質(zhì)量工程師和質(zhì)量體系提升提供領(lǐng)導(dǎo)和支持。
Partner closely with partner site for overall product and system compliance.
與各合作伙伴密切聯(lián)系，以保證整個(gè)產(chǎn)品和體系的適應(yīng)性。
Key Accountabilities:
Designs and deploys the quality system in the facilities
設(shè)置和部署公司的質(zhì)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(lǐng)QA部門，確保質(zhì)量體系的發(fā)展與符合FDA 質(zhì)量體系法規(guī)要求，符合ISO9001，ISO13485/8，MDD，CMDR，日本R-RAL和其它質(zhì)量要求。
Works closely with Site Leadership to enhance the overall effectiveness of quality system.
與各部門領(lǐng)導(dǎo)密切合作確保質(zhì)量體系在公司內(nèi)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(zhì)量項(xiàng)目和活動(dòng)，保證產(chǎn)品和裝配按照相應(yīng)的要求進(jìn)行開發(fā)和生產(chǎn)。
Leads Manufacturing and Supplier Quality Engineering aspect to drive technically strong and data driven decision process.
帶領(lǐng)制造和供應(yīng)商質(zhì)量工程方面往技術(shù)趨動(dòng)和數(shù)據(jù)趨動(dòng)決策過程發(fā)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(dǎo)和支持措施以確保有效的質(zhì)量報(bào)告，質(zhì)量體系、質(zhì)量改進(jìn)措施和顧客關(guān)注質(zhì)量；監(jiān)督管理質(zhì)量體系政策和程序手冊(cè)。
Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
支持和發(fā)展鑒定、分析、改正和預(yù)防質(zhì)量問題的體系。
Be part of CAPA board and drive related improvements in CAPA process.
作為CAPA團(tuán)隊(duì)的一員，推動(dòng)CAPA項(xiàng)目的發(fā)展。
Oversees returned product analysis and failure investigation activities for manufactured products.
負(fù)責(zé)監(jiān)督退貨產(chǎn)品分析和生產(chǎn)故障調(diào)查活動(dòng)。
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(jīng)驗(yàn)為產(chǎn)品的提高和生產(chǎn)轉(zhuǎn)化效率做貢獻(xiàn)，確保產(chǎn)品提高計(jì)劃和其他適用的要求能有效符合法規(guī)要求。
Manages, conducts and coordinates external (FDA, TUV, etc.) audits.
管理、引導(dǎo)和協(xié)助外部審核（包括FDA，TUV等）
Manages the design and manufacturing documentation and trace ability systems.
管理設(shè)計(jì)和生產(chǎn)的文件和追溯性系統(tǒng)。
Manages the QA Department including planning, budgeting, coaching, performance and salary reviews.
管理QA部門的計(jì)劃、預(yù)算、訓(xùn)練、績(jī)效和薪酬評(píng)估。
Provides QA support, participate and collaborate in division related projects.
為各部門有關(guān)項(xiàng)目提供QA支持、參與或協(xié)作。
Works with local management team members in developing long and short-term business goals and strategies.
在發(fā)展長(zhǎng)期、短期業(yè)務(wù)目標(biāo)和戰(zhàn)略中，與當(dāng)?shù)毓芾韴F(tuán)隊(duì)的成員合作。
Attributes:.
Sound business acumen
良好的商業(yè)頭腦
Highly developed people management skills
高度發(fā)達(dá)的人員管理能力
Self motivated, enthusiastic, positive
自我激勵(lì)，主動(dòng)熱情
Professional, cooperative, and customer service focused attitude
專業(yè)，協(xié)作，關(guān)注于顧客服務(wù)的態(tài)度。
Takes initiative to complete work tasks and works well in a team environment
主動(dòng)完成工作任務(wù)并能適應(yīng)團(tuán)隊(duì)工作環(huán)境
Leadership skills, team building and development
領(lǐng)導(dǎo)才能，團(tuán)隊(duì)建設(shè)和發(fā)展能力
Ability to initiate and lead process improvements
發(fā)起和領(lǐng)導(dǎo)過程改進(jìn)的能力。
Sensitivity to senior management’s needs and concerns
對(duì)管理的需求和關(guān)注點(diǎn)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(yī)藥管理、醫(yī)療器械或其它高度管制的制造業(yè)從業(yè)經(jīng)驗(yàn)。
Overall operational and financial acumen, Business and Project Management skills and experience a plus.
整體運(yùn)營(yíng)經(jīng)驗(yàn)及敏銳的財(cái)務(wù)意識(shí)，業(yè)務(wù)和項(xiàng)目管理技能和經(jīng)驗(yàn)者更佳。
Fluency in Quality System Regulation, MDD, and knowledge of Quality System Regulations and ISO.
熟悉質(zhì)量體系法規(guī)，MDD，掌握質(zhì)量體系法規(guī)和ISO知識(shí)。
Training in the following will be advantaged:
接受過以下培訓(xùn)項(xiàng)目者更佳
ISO Standards
JSO 標(biāo)準(zhǔn)
Basic Statistics
基礎(chǔ)統(tǒng)計(jì)學(xué)
Quality Auditing
質(zhì)量審核
Continuous Quality Im
