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職位描述：

1. 根據(jù)ISO 13485標(biāo)準(zhǔn)、EU法規(guī)和MDSAP法規(guī)以及公司內(nèi)部程序和要求，高效地執(zhí)行審核任務(wù)；
2. 按照審核流程要求，撰寫詳盡的審核報(bào)告，出具審核過程中發(fā)現(xiàn)問題的不合格報(bào)告和改進(jìn)建議；
3. 按照歐盟法規(guī)要求，對(duì)制造商提交的技術(shù)文件進(jìn)行及時(shí)的合規(guī)性評(píng)審；
4. 根據(jù)客戶需求，策劃和提供專業(yè)技術(shù)交流會(huì)和研討會(huì)，以為客戶提供有價(jià)值的技術(shù)支持；
5. 持續(xù)關(guān)注并學(xué)習(xí)醫(yī)療器械領(lǐng)域的最新法規(guī)、認(rèn)證和評(píng)審流程；
6. 積極參與授權(quán)的培訓(xùn)課程和交流會(huì)議，持續(xù)提升個(gè)人專業(yè)能力和知識(shí)水平。

職位要求：

1. 大學(xué)本科及以上學(xué)歷，生物醫(yī)學(xué)工程、臨床醫(yī)學(xué)、藥理學(xué)、生物學(xué)、材料學(xué)、生物化學(xué)等理工科專業(yè)；
2. 具有4年及以上醫(yī)療器械相關(guān)領(lǐng)域的工作經(jīng)驗(yàn)（研發(fā)，測(cè)試驗(yàn)證，質(zhì)量控制，法規(guī)注冊(cè)等），至少2年及以上的醫(yī)療器械的質(zhì)量管理工作經(jīng)驗(yàn)；
3. 熟悉歐盟醫(yī)療器械法規(guī)、ISO13485和MDSAP法規(guī)；
4. 熟悉無源醫(yī)療器械的相關(guān)標(biāo)準(zhǔn)如ISO 14971，ISO 10993，ISO 11135，ISO 11137等標(biāo)準(zhǔn)；
5. 英語聽說讀寫熟練，能撰寫英文報(bào)告；
6. 積極的工作態(tài)度，具備獨(dú)立工作和面對(duì)困境的能力，能適應(yīng)出差；
7. 愿意持續(xù)學(xué)習(xí)，具備良好的溝通能力和團(tuán)隊(duì)協(xié)作精神；
8. 具有CCAA的注冊(cè)審核員資格或者具有滅菌經(jīng)驗(yàn)或微生物專家優(yōu)先考慮。

Job Description:

1. Conduct audit tasks efficiently in accordance with the ISO 13485, EU regulations, MDSAP regulations, and the company's internal procedures and instructions;
2. Write audit reports according to the audit process requirements, issue deficiency reports for findings during the audit, and provide suggestions for improvement;
3. Perform timely compliance reviews on technical documents submitted by manufacturers in accordance with EU regulatory requirements;
4. Plan and provide professional technical exchanges and seminars based on customer needs to provide valuable technical support;
5. Continuously learn about the latest regulations, certifications, and review processes in the field of medical devices;
6. Actively participate in authorized training courses and exchange meetings to continuously improve personal professional skills and knowledge level.

Requirements:

1. Bachelor's degree or above in biomedical engineering, medicine, pharmacology, biology, materials science, biochemistry, or other related fields of science and engineering;
2. Own at least 4 years of work experience in the field of medical devices (including R&D, testing and validation, quality control, regulatory/registration, etc.), and with at least 2 years of experience in quality management of medical devices;
3. Familiar with EU medical device regulations, ISO 13485, and MDSAP regulations;
4. Familiar with related non-active medical device standards such as ISO 14971, ISO 10993, ISO 11135, ISO 11137, etc.;
5. Proficient in English listening, speaking, reading, and writing, capable of writing reports in English;
6. Have a positive work attitude, the ability to work independently and face challenges, and be willing to travel;
7. Willing to continue learning, with good communication skills and a team spirit;
8. CCAA registered auditor or experts with sterilization experience or expertise in microbiology are preferred.