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To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a MRA Engineer located in Suzhou Suqian.
Reporting to the MRA Manager the MRA Engineer role involves…
What a typical day looks like:
61 協(xié)助法規(guī)事務(wù)經(jīng)理制定、實施和維護(hù)有效的質(zhì)量管理體系，以符合醫(yī)療器械適用法規(guī) (如:醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范、美國聯(lián)邦法規(guī)食品藥品監(jiān)督管理局-21條 質(zhì)量體系法規(guī)等)和適用標(biāo)準(zhǔn)(如:YY/T0287/ ISO13485)要求。
Assist MRA Manager to develop, implement and maintain an effective quality management system to comply with applicable regulations for medical device (e.g., Good Manufacturing Practice for Medical Devices, 21 CFR Part 820, etc.) and applicable standards (e.g., YY/T0287/ ISO13485).
61 評審過程和軟件確認(rèn)及驗證活動，以符合上述法規(guī)和適用標(biāo)準(zhǔn)
Review the process and software validation activities to ensure the validation processes fully comply the above requirements.
61 協(xié)助法規(guī)事務(wù)經(jīng)理管理質(zhì)量管理體系文件，組織管理評審會議和準(zhǔn)備相關(guān)材料。
Assist MRA Manager to manage quality management system documents, organize management review meeting and prepare related data and files.
61 作為審核協(xié)調(diào)員，根據(jù)醫(yī)療器械適用法規(guī)標(biāo)準(zhǔn)的要求，計劃和協(xié)調(diào)質(zhì)量管理體系內(nèi)部審核活動。
Act as internal audit coordinator need to plan and coordinate QMS internal audit activities in accordance with available regulations and standards for medical devices.
61 作為糾正預(yù)防措施工程師/協(xié)調(diào)員，確保糾正預(yù)防措施有效實施、評價和監(jiān)督以及及時關(guān)閉。
Act as CAPA engineer/coordinator to ensure to implement, evaluate and monitor corrective actions and preventive actions effectively and close in time manner.
61 協(xié)助法規(guī)事務(wù)經(jīng)理協(xié)調(diào)配合監(jiān)管機(jī)構(gòu)以及第三方審核機(jī)構(gòu)的審核或檢查，參與并支持客戶審核活動。
Assist MRA Manager to coordinate the audit or inspection from third-party notify body and regulatory authorities and support customer audit activities.
61 上級安排的其他工作。
The other works assigned by superior.
The experience we’re looking to add to our team:
61 大學(xué)?？苹?qū)？埔陨?br />College or above
61 3年以上醫(yī)療器械行業(yè)質(zhì)量工程或質(zhì)量管理體系相關(guān)工作經(jīng)驗。
3 years or above working experience in quality engineering or quality management system for medical device.
61 有PCBA和電子產(chǎn)品組裝過程的相關(guān)工作經(jīng)驗。
Be experienced in PCBA and electronics product assembly process.
61 有醫(yī)療驗證經(jīng)驗的優(yōu)先考慮
Medical Validation experience is preferred.
61 熟悉醫(yī)療質(zhì)量管理體系（如YY/T0287/ISO13485）以及醫(yī)療器械相關(guān)法規(guī)（醫(yī)療器械監(jiān)督管理條例、醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范）的要求。
Familiar with the requirements of medical quality management system (such as YY/T0287/ ISO13485) and relevant regulations on medical devices (Regulations on supervision and Administration of Medical Devices.
61 具備理解和實施內(nèi)部審核的知識和能力。
Knowledge and ability to understand and implement internal audits of QMS.
61 良好的溝通、表達(dá)、人際關(guān)系和組織能力。
Good skills of communication, presentation, interpersonal relationships and organization.
61 積極主動、獨(dú)立工作的能力和良好的團(tuán)隊合作精神。
Initiative, independent and good team player.
What you’ll receive for the great work you provide:
61 Social Insurance
61 Life Insurance
61 PTO