工作職責(zé)： Responsibilities (fundamental job duties): 負(fù)責(zé)質(zhì)量管理體系的建立和維護(hù)，以符合FDA QSR, ISO13485及歐盟醫(yī)療器械指令的要求。 Be responsible for the establishment and maintenance of the quality management system, which is in compliance with FDA QSR, ISO 13485 and MDD 93/42 EEC. 定期向管理層報(bào)告質(zhì)量管理體系的運(yùn)行情況。 Report to top management, at a regular basis, the performance of the quality management system. 負(fù)責(zé)供應(yīng)商質(zhì)量管理。 Be responsible for supplier quality management. 負(fù)責(zé)產(chǎn)品放行的批準(zhǔn)。 Be responsible for approval of product acceptance. 負(fù)責(zé)組織不合格品評審。 Be responsible for nonconforming product review. 根據(jù)技術(shù)規(guī)范的要求，制訂新產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)。 Base on the technical specification, set up quality standards and specifications for new products. 負(fù)責(zé)準(zhǔn)備和協(xié)調(diào)與質(zhì)量管理體系有關(guān)的審核或檢查。 Be responsible for the coordination and preparation of external audits or inspections to quality management system. 負(fù)責(zé)糾正預(yù)防措施的實(shí)施和驗(yàn)證。 Be responsible for the implementation and verification of corrective and preventive actions. 負(fù)責(zé)與質(zhì)量管理體系有關(guān)的數(shù)據(jù)分析。 Be responsible for quality management system related data analysis. 負(fù)責(zé)客戶抱怨的處理。 Be responsible for customer complaint handling. 負(fù)責(zé)質(zhì)量管理體系的策劃。 Be responsible for quality management system planning. 負(fù)責(zé)產(chǎn)品設(shè)計(jì)開發(fā)的評審， 風(fēng)險(xiǎn)管理和更改控制。 Responsible for product design and development review, risk management and change control. 參與過程確認(rèn)。 Participate in process validation. 參與質(zhì)量管理體系內(nèi)審和管理評審。 Participate in quality management system internal audit and management review. 工作勝任要求： Minimum Requirements: 本科以上學(xué)歷； Bachelor degree or above; 5年以上質(zhì)量管理體系運(yùn)行經(jīng)驗(yàn)，一次性醫(yī)療器械或塑料制品行業(yè)工作經(jīng)驗(yàn)優(yōu)先; 5 years relevant experience in quality management system, with experience in single use medical device or plastic products industry is a plus； 國家注冊質(zhì)量工程師優(yōu)先； China Registered Quality Engineer is a plus; 具有ISO9001/ISO3485/ISO4001 內(nèi)審員資格優(yōu)先； ISO9001/ISO13485/ISO14001 internal auditor is a plus; 較強(qiáng)的領(lǐng)導(dǎo)力； Strong leadership; 良好的口頭及書面溝通能力； Good communication skills (both verbal and written); 中英文流利。 Be proficient in both English and/or Mandarin Chinese.