基本信息
工作性質(zhì)全職
招聘人數(shù)1人
招聘部門不限
學(xué)歷要求本科
工作經(jīng)驗(yàn)1-3年
年齡要求不限
工作地點(diǎn)宜興市新街街道綠園路888-8號（江蘇/無錫/宜興市）
聯(lián)系方式
聯(lián)系人：Vanessa ( 聯(lián)系我時，請說是在宜興人才網(wǎng)上看到的 )
聯(lián)系電話：0510-0512-6****803
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職位動態(tài)
100%
近兩周該職位的簡歷處理率
簡歷處理率0天
簡歷平均處理時長
2019-08-08
企業(yè)最近登錄時間
職位描述
POSITION SUMMARY（職位概述）
Take the responsibility of QA engineer for ensuring product quality realized with applying QMS requirements, product specification, production process control plan, quality analysis tools.
確保產(chǎn)品質(zhì)量控制活動遵循了質(zhì)量管理體系、產(chǎn)品規(guī)范、生產(chǎn)工藝、控制計劃的要求，并且應(yīng)用恰當(dāng)?shù)馁|(zhì)量分析工具。
KEY RESPONSIBILITIES（主要職責(zé)）
1. Production process management: check the quality control point for each key production steps, check the line clearance and cleaning results. Responsible for release of bulk product.
生產(chǎn)過程管理：對每批產(chǎn)品生產(chǎn)各環(huán)節(jié)的質(zhì)量控制點(diǎn)進(jìn)行檢查， 對車間清場、清潔結(jié)果進(jìn)行檢查。負(fù)責(zé)車間半成品的放行。
2. Reviewing for incoming test of raw material. Reviewing for batch production record, batch analytical record.
審核到貨檢驗(yàn)結(jié)果。審核批生產(chǎn)記錄和批檢驗(yàn)記錄。
3. Following the set-up quality procedures to handle quality issue with product processing from assembly, molding, filling and packing.
根據(jù)即定的質(zhì)量程序處理來自裝配、注塑、灌裝和包裝過程的產(chǎn)品質(zhì)量問題。
4. Involve in root cause and action addressing to QN/deviation/CAPA. Involve in evaluation and action addressing to change control management.
參入質(zhì)量事件/偏差/ CAPA的根本原因調(diào)查和措施跟蹤，參入變更控制的評估流程和行動的跟蹤。
5. Review validation protocol and validation report. And responsible of sampling for validation sample and monitoring for execution of validation activities.
審核驗(yàn)證方案和驗(yàn)證報告。在驗(yàn)證執(zhí)行過程中負(fù)責(zé)取樣并監(jiān)督驗(yàn)證的執(zhí)行。
6. Prepare relevant quality assurance procedure. Leading for preparing for control plan, p-FMEA, quality plan, etc
起草質(zhì)量保證相關(guān)流程。領(lǐng)導(dǎo)建立控制計劃、P-FMEA、質(zhì)量計劃等文件。
7. Responsible for sampling for product, retention sample and periodic inspection
負(fù)責(zé)車間取樣、留樣產(chǎn)品和周期檢驗(yàn)。
8. Involve in supplier management, include supplier qualification evaluation, on-site audit, performance evaluation, compliant to supplier etc.
參入供應(yīng)商管理，包括供應(yīng)商初始確認(rèn)評估、現(xiàn)場審計、供應(yīng)商績效評估、供應(yīng)商投訴等。
9. Support operation engineer for investigation to customer complaint and review investigation report for the result corrective, and accurate addressing customer complaint.
支持生產(chǎn)部工程師對客戶投訴進(jìn)行調(diào)查，并審核調(diào)查報告及措施，精確解決客戶投訴。
10. Aware to national standard/regulation requirements of products for driving product compliance.
了解國家標(biāo)準(zhǔn)和法規(guī)要求并推動產(chǎn)品符合相應(yīng)的要求。
11. EHS compliance in the responsible area
負(fù)責(zé)區(qū)域的EHS合規(guī)。
12. Other superior assigned work
上級指派其它的工作。
SKILLS AND ABILITIES（技能） 1. Bachelor degree with major for bio, pharma engineering relevant, or production mechanism/electronic/automation engineering relevant
本科或以上學(xué)歷畢業(yè)，生物工程，制藥工程相關(guān)專業(yè)， 或機(jī)電工程自動化生產(chǎn)相關(guān)。
2. At least 3 years relevant work experience of QA engineers or supervisors in medical devices companies
至少3年以上醫(yī)療器械企業(yè)QA工程師或主管的相關(guān)工作經(jīng)驗(yàn)
3. Be familiar with relevant regulation requirements for medical devices, medical devices GMP requirements; medical device GMP/ISO 13485 requirements
熟悉國家有關(guān)的醫(yī)療器械的法規(guī)、熟悉醫(yī)療器械GMP要求、熟悉醫(yī)療器械GMP/ISO 13485要求。
4. team player with well communicative and cooperative,
具有良好溝通和協(xié)作能力的團(tuán)隊成員
5. Fluent in listening and speaking in English and Chinese
中英文聽說讀寫流利；
Take the responsibility of QA engineer for ensuring product quality realized with applying QMS requirements, product specification, production process control plan, quality analysis tools.
確保產(chǎn)品質(zhì)量控制活動遵循了質(zhì)量管理體系、產(chǎn)品規(guī)范、生產(chǎn)工藝、控制計劃的要求，并且應(yīng)用恰當(dāng)?shù)馁|(zhì)量分析工具。
KEY RESPONSIBILITIES（主要職責(zé)）
1. Production process management: check the quality control point for each key production steps, check the line clearance and cleaning results. Responsible for release of bulk product.
生產(chǎn)過程管理：對每批產(chǎn)品生產(chǎn)各環(huán)節(jié)的質(zhì)量控制點(diǎn)進(jìn)行檢查， 對車間清場、清潔結(jié)果進(jìn)行檢查。負(fù)責(zé)車間半成品的放行。
2. Reviewing for incoming test of raw material. Reviewing for batch production record, batch analytical record.
審核到貨檢驗(yàn)結(jié)果。審核批生產(chǎn)記錄和批檢驗(yàn)記錄。
3. Following the set-up quality procedures to handle quality issue with product processing from assembly, molding, filling and packing.
根據(jù)即定的質(zhì)量程序處理來自裝配、注塑、灌裝和包裝過程的產(chǎn)品質(zhì)量問題。
4. Involve in root cause and action addressing to QN/deviation/CAPA. Involve in evaluation and action addressing to change control management.
參入質(zhì)量事件/偏差/ CAPA的根本原因調(diào)查和措施跟蹤，參入變更控制的評估流程和行動的跟蹤。
5. Review validation protocol and validation report. And responsible of sampling for validation sample and monitoring for execution of validation activities.
審核驗(yàn)證方案和驗(yàn)證報告。在驗(yàn)證執(zhí)行過程中負(fù)責(zé)取樣并監(jiān)督驗(yàn)證的執(zhí)行。
6. Prepare relevant quality assurance procedure. Leading for preparing for control plan, p-FMEA, quality plan, etc
起草質(zhì)量保證相關(guān)流程。領(lǐng)導(dǎo)建立控制計劃、P-FMEA、質(zhì)量計劃等文件。
7. Responsible for sampling for product, retention sample and periodic inspection
負(fù)責(zé)車間取樣、留樣產(chǎn)品和周期檢驗(yàn)。
8. Involve in supplier management, include supplier qualification evaluation, on-site audit, performance evaluation, compliant to supplier etc.
參入供應(yīng)商管理，包括供應(yīng)商初始確認(rèn)評估、現(xiàn)場審計、供應(yīng)商績效評估、供應(yīng)商投訴等。
9. Support operation engineer for investigation to customer complaint and review investigation report for the result corrective, and accurate addressing customer complaint.
支持生產(chǎn)部工程師對客戶投訴進(jìn)行調(diào)查，并審核調(diào)查報告及措施，精確解決客戶投訴。
10. Aware to national standard/regulation requirements of products for driving product compliance.
了解國家標(biāo)準(zhǔn)和法規(guī)要求并推動產(chǎn)品符合相應(yīng)的要求。
11. EHS compliance in the responsible area
負(fù)責(zé)區(qū)域的EHS合規(guī)。
12. Other superior assigned work
上級指派其它的工作。
SKILLS AND ABILITIES（技能） 1. Bachelor degree with major for bio, pharma engineering relevant, or production mechanism/electronic/automation engineering relevant
本科或以上學(xué)歷畢業(yè)，生物工程，制藥工程相關(guān)專業(yè)， 或機(jī)電工程自動化生產(chǎn)相關(guān)。
2. At least 3 years relevant work experience of QA engineers or supervisors in medical devices companies
至少3年以上醫(yī)療器械企業(yè)QA工程師或主管的相關(guān)工作經(jīng)驗(yàn)
3. Be familiar with relevant regulation requirements for medical devices, medical devices GMP requirements; medical device GMP/ISO 13485 requirements
熟悉國家有關(guān)的醫(yī)療器械的法規(guī)、熟悉醫(yī)療器械GMP要求、熟悉醫(yī)療器械GMP/ISO 13485要求。
4. team player with well communicative and cooperative,
具有良好溝通和協(xié)作能力的團(tuán)隊成員
5. Fluent in listening and speaking in English and Chinese
中英文聽說讀寫流利；
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