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We seek an experienced and motivated QA/RA/Process Engineer with a background in Electronics and Mechanics to supervise our aesthetic medical device production in China.
The ideal candidate will have at least five years of experience in the medical device or electronics industry, a strong background in quality assurance, and a comprehensive understanding of the processes required to meet product standards and requirements.
This proposed position includes but is not limited to: qualification/monitoring of critical sub-contractors, maintaining the quality and the procedures of our production line(s), training new workers, ensuring compliance with medical standards and regulatory requirements, and providing technical support.
Key Qualifications:
Education in relevant engineering studies
High English level, speaking and writing
Minimum five years of experience in the medical device and/or electronics industry
Strong quality assurance background, specifically in Supplier Qualification and monitoring
Comprehensive understanding of processes required to meet product standards and requirements
Results-driven and able to work well under pressure
Proficient in presenting technical information
Excellent interpersonal communication skills
Strong teamwork capabilities
Qualified Lead Auditor for Medical Devices (at least ISO 13485 and 21 CFR 820, additional qualification for EUMDR is preferable)
Priority shall be given to knowledge and experience with Low Voltage Directive, GHTF for Process Validation and GAMP5
Experience with Process Validation and Software Tool Validation as per ISO 13485, 21 CFR 820 and GHTF
At least five years of experience
Responsibilities:
Maintain production line quality and procedures, ensuring adherence to industry standards and best practices
Train new workers on production processes and quality assurance protocols
Ensure compliance with medical / non-medical standards and regulatory requirements
Supervise the component acceptance process, guaranteeing that all critical components meet necessary specifications
Provide technical support for any mechanical / electronic issues with the production line and equipment
Supplier Qualification and monitoring
Supplier Audits
Serve as the primary contact point for any quality and production-related issues or concerns
Reports to the QA/RA and/or Engineering Manager, providing updates on production line status, challenges, and progress
我們尋求一位具有電子和機(jī)械背景的經(jīng)驗(yàn)豐富、積極進(jìn)取的QA/QC/工藝工程師來(lái)監(jiān)督我們?cè)谥袊?guó)的美容醫(yī)療器械生產(chǎn)。
理想的候選人將在醫(yī)療器械或電子行業(yè)擁有至少五年的經(jīng)驗(yàn)，具有強(qiáng)大的質(zhì)量保證背景，并對(duì)滿足產(chǎn)品標(biāo)準(zhǔn)和要求所需的流程有全面的了解。
這一擬議職位包括但不限于：關(guān)鍵分包商的資格認(rèn)證/監(jiān)督，維持我們生產(chǎn)線的質(zhì)量和程序，培訓(xùn)新工人，確保遵守醫(yī)療標(biāo)準(zhǔn)和監(jiān)管要求，以及提供技術(shù)支持。
主要資質(zhì)：
相關(guān)工程研究教育
英語(yǔ)水平高，口語(yǔ)和寫作能力強(qiáng)
至少五年醫(yī)療器械和/或電子行業(yè)工作經(jīng)驗(yàn)
強(qiáng)大的質(zhì)量保證背景，特別是在供應(yīng)商資格和監(jiān)督方面
全面了解滿足產(chǎn)品標(biāo)準(zhǔn)和要求所需的流程
注重成果，能夠在壓力下良好工作
精通技術(shù)信息展示
優(yōu)秀的人際溝通能力
強(qiáng)大的團(tuán)隊(duì)合作能力
合格的醫(yī)療器械首席審計(jì)員（至少ISO 13485和21 CFR 820，***有EUMDR的額外資格）
應(yīng)優(yōu)先考慮低壓指令、工藝驗(yàn)證GHTF和GAMP5方面的知識(shí)和經(jīng)驗(yàn)
根據(jù)ISO 13485、21 CFR 820和GHTF進(jìn)行過(guò)程驗(yàn)證和軟件工具驗(yàn)證的經(jīng)驗(yàn)
至少五年的工作經(jīng)驗(yàn)
職責(zé)：
維護(hù)生產(chǎn)線質(zhì)量和程序，確保遵守行業(yè)標(biāo)準(zhǔn)和***實(shí)踐
對(duì)新工人進(jìn)行生產(chǎn)流程和質(zhì)量保證協(xié)議方面的培訓(xùn)
確保符合醫(yī)療/非醫(yī)療標(biāo)準(zhǔn)和監(jiān)管要求
監(jiān)督部件驗(yàn)收過(guò)程，確保所有關(guān)鍵部件符合必要的規(guī)范
為生產(chǎn)線和設(shè)備的任何機(jī)械/電子問(wèn)題提供技術(shù)支持
供應(yīng)商資格鑒定和監(jiān)督
供應(yīng)商審核
作為任何質(zhì)量和生產(chǎn)相關(guān)問(wèn)題或關(guān)注點(diǎn)的主要聯(lián)絡(luò)點(diǎn)
向QA/QC和/或工程經(jīng)理報(bào)告，提供生產(chǎn)線狀態(tài)、挑戰(zhàn)和進(jìn)展的最新情況