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更新于 7月17日
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QA專員

1-1.5萬(wàn)·13薪
  • 北京大興區(qū)
  • 亦莊
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

QA醫(yī)藥制造醫(yī)療設(shè)備/器械
Description:
The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The QA Engineer is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and service.
The QA Engineer may lead programs and initiatives and/or have responsibility for coaching more junior engineers
Key responsibilities/essential functions include:
? Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
? Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
? Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools.
? Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
? Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
? Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
? Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
? Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
? Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Meet NPI program milestone dates while approving compliance status of each
5. Ensure 100% completion/closure of all SPRs/risks before product release to market
6. Ensure 100% on time CAPA closure for engineering investigations
Required Qualifications:
1. Bachelors Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).
2. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
3. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
4. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
5. Demonstrated collaboration, negotiation & conflict resolution skills.
6. English as working language.
Preferred Qualifications:
1. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
2. Excellent oral communication & report, business correspondence & procedure-writing skills
3. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
4. Change agent with energy, passion & enthusiasm to drive change
5. Exceptional analytical, problem solving & root-cause analysis skills
6. Ability to multi-task & handle tasks with competing priorities effectively
7. External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
8. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely
基本要求：
有研發(fā)經(jīng)歷或者背景的質(zhì)量審核或法規(guī)注冊(cè)相關(guān)經(jīng)驗(yàn)；如無(wú)，則需要有生產(chǎn)質(zhì)量工作背景；
英語(yǔ)要能夠進(jìn)行聽說讀寫，因?yàn)榕c國(guó)外交流的機(jī)會(huì)很多；
良好的溝通能力。

工作地點(diǎn)

北京大興區(qū)亦莊同濟(jì)南路1號(hào)

職位發(fā)布者

李靖文/招聘專員

今日活躍
立即溝通
華信永益(北京)信息技術(shù)有限公司
華信永益創(chuàng)建于享有中國(guó)硅谷美譽(yù)的北京中關(guān)村，公司凝聚了擁有理想與智慧的IT行業(yè)精英人才，專門從事應(yīng)用軟件開發(fā)、軟件外包、信息系統(tǒng)集成、互聯(lián)網(wǎng)技術(shù)與應(yīng)用開發(fā)的高科技企業(yè)。我們致力于為各行業(yè)客戶提供完美的解決方案，共同打造一家“懂得需求落地、力求完美體驗(yàn)”的公司。我們致力于追求客戶利益最大化、追求優(yōu)質(zhì)滿意的服務(wù)、追求可持續(xù)發(fā)展的戰(zhàn)略方針、追求以人為本的生存之道，致力于為我們的客戶提供完美的解決方案和一流的IT服務(wù)。華信永益公司高管團(tuán)隊(duì)來(lái)聯(lián)想集團(tuán)、中軟集團(tuán)和東軟集團(tuán)高級(jí)管理職位，擁有豐富的經(jīng)營(yíng)和管理經(jīng)驗(yàn)，技術(shù)負(fù)責(zé)人曾任亞信、用友等公司的CTO，是美國(guó)PMI協(xié)會(huì)PMP會(huì)員、高級(jí)信息項(xiàng)目管理師，中國(guó)系統(tǒng)與軟件過程改進(jìn)協(xié)會(huì)主任專家會(huì)員，擁有著豐富的技術(shù)和項(xiàng)目管理經(jīng)驗(yàn)。
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