職位描述
無源醫(yī)療器械技術(shù)文件審核醫(yī)療設(shè)備/器械檢測/認證
I.Position Summary
This position is responsible for performing product and technical documentation assessment in the field of Non-Active Medical Product (NAM) and delivery the assessment result to support the certification decision.
II.Job Responsibilities
Assessment Project handling (weight 80%)
1.Perform product assessment according to standard requirements, regulatory requirements, internal requirements, code of conduct.
2.Review technical documentation of the manufacturers and give the suggestion of certification decision.
3.Develop the technical capacity of the authorized product scope
4.Handle customer complaint or inquiry from competent authorities
5.Support sales and marketing activities in technical field
Operating support (weight 20%)
6.Support the daily operation of auditing section
7.Perform other duties assigned by Department Manager
III.Job Requirements
1.Bachelor’s degree or above in Biology, Biotechnology Engineering, human medicine, Chemical Engineering, Material Engineering or the similar majors. Master degree is preferred.
2.Minimum 5 years working experience in the fields of medical device design / production / product quality control or similar working experience.
3.Good command of English.
4.Working experience in quality system management is preferred.
5.Good communication and interpersonal skills
6.Diligence; strong teamwork spirit; self-motivation, and self-improvement
7.Can work independently and efficiently and work under pressure
工作地點
天津和平區(qū)津匯廣場2座
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SGS
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職位發(fā)布者
郭宏宇/HR
三日內(nèi)活躍立即溝通
南德認證檢測(中國)有限公司北京分公司Established in Germany 140 years ago, TüV SüD is one of the world's leading technical services providers, offering knowledge services, inspections, testing, expert opinions, audit/certification and training. Approximately 14,000 employees at over 600 locations worldwide provide technology, system and know-how optimisation.The headquarter of TüV SüD Greater China Region locates in Shanghai, around 30 satellite offices throughout the region, TüV SüD is an important supporting bridge between international trade partners. Around 1, 100 dedicated experts and trained staff support customers to position new products, services and systems for global acceptance. We continue to expand and innovate constantly to expand our product portfolio as per our clients’ requirements. TüV SüD Beijing Region established in 2004. With the vigorous development, it has become one of the most potential Regions that grew fastest. Beijing is the head office of TüV SüD North Region, with satellite offices in Tianjin, Changchun, Shenyang, Dalian, Qiangdao. Over 200 employees in those offices offers knowledge services, inspections, testing, expert opinions, certification and training, covering the business units of trade services, electronic services, consumers products, Medical and Health Services, Softlines(textiles, clothing& footwear), Industry services, chemical services, Automotive and rail, Management services, Telecommunications and so on. 140年前誕生于德國， TüV南德意志集團是業(yè)內(nèi)領(lǐng)先的技術(shù)服務(wù)公司，為您提供資訊，檢驗，測試，專家意見，審核/認證和培訓(xùn)服務(wù)。14,000多名員工遍及全球600多個辦事處，著力為您實現(xiàn)技術(shù)、體系和實際運作中的優(yōu)化服務(wù)。TüV南德意志集團大中華區(qū)的總部設(shè)在上海，約30個分支機構(gòu)貫穿整個區(qū)域，TüV南德意志集團是國際貿(mào)易合作的重要支持橋梁。在中國，約1100名專注于各個領(lǐng)域的專家和訓(xùn)練有素的工作人員向客戶提供支持，致力于新產(chǎn)品的推廣，服務(wù)和體系為全球所接受。我們持續(xù)地發(fā)展與創(chuàng)新，順應(yīng)客戶要求不斷擴大我們的服務(wù)范圍。TüV SüD北京于2004年成立至今，蓬勃發(fā)展，現(xiàn)已發(fā)展成為以北京為核心，輻射天津，長春，沈陽，大連，青島等北方區(qū)域，是南德集團大中華區(qū)發(fā)展最快，潛力最大的分支機構(gòu)之一。6個辦公室超過200名員工為客戶提供涉及貿(mào)易服務(wù),電子產(chǎn)品,消費品，醫(yī)療器械，紡織品，服裝和化學(xué)產(chǎn)品，工業(yè)服務(wù)，化工服務(wù)，汽車和鐵路，管理服務(wù)及通訊方面的測試、檢驗、認證、培訓(xùn)服務(wù)和知識服務(wù)。
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