【請(qǐng)注意工作地點(diǎn)為：蘇州】

負(fù)責(zé)公司質(zhì)量管理體系建設(shè)、維護(hù)和管理工作；并對(duì)質(zhì)量管理制度的執(zhí)行情況進(jìn)行檢查、糾正和持續(xù)改進(jìn)
Responsible for the Quality Management System Construction, maintenance, management. And monitor, correct and continuous improve the implementation of Quality Management System
受控文件的定期回顧
Take charge for periodic review of controlled documentation
負(fù)責(zé)質(zhì)量管理體系、相關(guān)程序文件、法規(guī)要求，以及操作系統(tǒng)的培訓(xùn)
Responsible for the training of Quality Management System, related procedure & regulatory demand, and operating system
公司ISO 13485證書(shū)的有效性維持
ISO 13485 certificate valid maintenance
負(fù)責(zé)糾正預(yù)防措施（CAPA）、以及NC的跟蹤和管理
In charge of CAPA and NC follow up and management
策劃和實(shí)施公司年度管理評(píng)審
Organize and implement annual management review
組織和實(shí)施蘇州工廠(chǎng)的定期內(nèi)部審核
Organize and implement regular audit in Suzhou Plant
負(fù)責(zé)來(lái)自集團(tuán)公司的審核；以及審計(jì)機(jī)構(gòu)和客戶(hù)的外部審核
In charge of audit come from Headquarter, thirty-party and customer
與總部公司保持密切、友好的溝通；確保質(zhì)量體系及程序文件的適用性、符合性
Keep close and good communication with headquarter company. Deal well with the applicability and compliance in Quality System and Procedure
完成上級(jí)領(lǐng)導(dǎo)交辦的其它工作
Finish the other jobs assigned by manager
任職要求：
本科或以上學(xué)歷Bachelor degree or above
1. 從事醫(yī)療器械質(zhì)量體系管理8年以上工作經(jīng)驗(yàn)；熟悉ISO 13485 / FDA 21CFR 820 / MDD 93/42/EEC等法規(guī)要求 With more than 5years QMS in medical device. Familiar with ISO 13485, FDA 21CFR 820 / MDD 93/42/EEC regulatory requirement, etc.
2.必須具備醫(yī)療器械工廠(chǎng)關(guān)于FDA QSR 820（21 CFR PART 820）的審核經(jīng)驗(yàn) Must have the audit experience of FDA QSR 820（21 CFR PART 820）in medical device factory.
3.具備醫(yī)療器械工廠(chǎng)GMP認(rèn)證經(jīng)驗(yàn) Have the experience of GMP certification regarding medical device factory.
4. 必須對(duì)ISO 13485非常了解Must be well understand about ISO 13485
5. 具備ISO 13485內(nèi)審員證書(shū)Have the internal auditor certificate of ISO 13485
6. 必須具備獨(dú)立接待來(lái)自審計(jì)機(jī)構(gòu)和客戶(hù)等外部審核的能力 Must have the ability of independent reception external audit which come from audit authority and client, etc.
7. 抗壓能力強(qiáng)。正直誠(chéng)信，仔細(xì)，責(zé)任心、執(zhí)行力、學(xué)習(xí)能力強(qiáng)。Strong ability to work under pressure. Honest, cautious, and strong sense of responsibility, execution, learning capability.
8. 必須具備獨(dú)立完成工作的能力、有主見(jiàn)。Must have the ability to work independently, and he or she should be strong-minded people.
9. 具備在集團(tuán)公司內(nèi)跨公司、跨部門(mén)較強(qiáng)溝通協(xié)作的能力 Strong ability to communicate and coordinate with cross function departments in group company.
10. 熟悉日常辦公軟件的使用，Word，Excel，PPT技巧熟練 Familiar with the use of daily office software, skilled at word, excel and PPT
11. 英語(yǔ)聽(tīng)說(shuō)讀寫(xiě)能力良好。With good English spoken and writing ability.

The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world.? Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices.????? Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices.? Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team.? The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.

http://www.sol-m.com