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Are you ready to embark on an exciting professional journey where innovation, collaboration, and excellence are at the heart of everything we do? Look no further! We are seeking passionate individuals like you to join our dynamic team.
職位概述：
This position is responsible for conducting audit/technical documentation review in Active Medical Product (AMP). For the purpose of international medical device regulatory approval.
該職位的主要職責(zé)是在大中國(guó)區(qū)范圍內(nèi)針對(duì)有源醫(yī)療器械產(chǎn)品進(jìn)行審核和技術(shù)文件評(píng)審工作，以滿足有源醫(yī)療器械制造商的國(guó)際市場(chǎng)準(zhǔn)入要求。
崗位職責(zé)：
1. Conduct auditing/technical documentation review according to standard requirements, regulatory requirements, procedures and code of conduct;
按照標(biāo)準(zhǔn)、法規(guī)、程序及行為準(zhǔn)則實(shí)施現(xiàn)場(chǎng)審核及技術(shù)文件評(píng)審
2. Maintain customer communication as project leader for the allocated customers regarding auditing and certification.
作為項(xiàng)目主管，就審核、認(rèn)證方面的要求和客戶進(jìn)行技術(shù)交流
3. Support relevant in AMP field for customer service, increase customer satisfaction;
支持有源醫(yī)療器械相關(guān)的客戶服務(wù)，提升客戶滿意度；
4. Know well about all policy of TüV SüD , procedures related to medical device business, with qualification as medical device in certain area;
充分理解TUV南德和醫(yī)療器械業(yè)務(wù)相關(guān)的正常、流程，保持醫(yī)療器械相關(guān)領(lǐng)域的審核資質(zhì)；
5. Maintain and develop skills in the field of standard, regulation, medical device (e.g. familiar with the product knowledge and standard requirements, follow the latest standard and regulation).
保持和提升在標(biāo)準(zhǔn)、法規(guī)、醫(yī)療器械產(chǎn)品方面的技能（例如：熟悉專業(yè)領(lǐng)域的產(chǎn)品知識(shí)及標(biāo)準(zhǔn)要求、跟蹤標(biāo)準(zhǔn)法規(guī)的最新動(dòng)態(tài)）
任職條件：
1. At least bachelor degree with diploma in active medical device related major (e.g. Biomedical Engineering, Electronic Engineering, Automatic Control);
本科及以上學(xué)歷，有源醫(yī)療器械相關(guān)專業(yè)（例如，生物醫(yī)學(xué)工程，電子工程，自動(dòng)控制）；
2. At least 3 years working experience in the field of active medical device;
3年及以上有源醫(yī)療器械相關(guān)工作經(jīng)驗(yàn)；
3. At least 2 years quality management working experience(e.g. manufacturing, quality control, or research);
2年及以上質(zhì)量管理工作經(jīng)驗(yàn)（例如，生產(chǎn)、質(zhì)量控制、研發(fā)）；
4. Diligence, self-motivation, self-improvement and strong teamwork spirit;
具有勤奮、主動(dòng)、自我改進(jìn)以及充分的團(tuán)隊(duì)合作精神；
5. Good communication and interpersonal skills;
具有良好的溝通和人際交往能力；
6. Can work independently and efficiently, can work under pressure;
能夠獨(dú)立、有效工作，能承受壓力；
7. Good computer skill;
具有良好的電腦操作技能；
8. Good command of English;
具有良好的英語(yǔ)能力；
9. Physical condition allows normal working, stable outputs and business trip as required.
身體條件允許正常穩(wěn)定的工作、能適應(yīng)出差；
10.CCAA qualification is preferable
具有CCAA注冊(cè)審核員資格優(yōu)先；
11.Work experience with medical device standards/regulation (e.g.ISO 13485, ISO 14971, IEC 60601-1, MDD or MDR) is preferable
具有醫(yī)療器械標(biāo)準(zhǔn)法規(guī)經(jīng)驗(yàn)（例如，ISO 13485, ISO 14971, IEC 60601-1, MDD 或 MDR）優(yōu)先。
**How to Apply**
If you are ready to take the next step in your career and join a team that embraces creativity, fosters innovation, and rewards excellence, we would love to hear from you! Please apply with detailed resume, stating expected salary and date of availability to Human Resources Department by clicking 'Apply Now'.
TUV SUD is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Join us on this incredible journey of transformation!
(Data collected will be treated as strictly confidential and will be used for recruitment purpose only)