此崗位需要良好的英語口語
主要職責(zé)
1. 管理生產(chǎn)中遇到的問題的解決方案。Supervise the resolution of problems encountered in production.
- 對生產(chǎn)中遇到的任何故障進(jìn)行系統(tǒng)和結(jié)構(gòu)化的分析。Implement a systematic and structured analysis of any malfunction encountered in production.
- 管理這些故障的分析和解決。Supervise the analysis and resolution of these malfunctions.
- 根據(jù)生產(chǎn)批記錄流程和生產(chǎn)計(jì)劃的要求故障儀器進(jìn)行診斷，以確保產(chǎn)品釋放Troubleshoot instruments to enable their release in accordance with the DHR procedures and the production schedule.
- 利用這些分析提出改進(jìn)或預(yù)防措施:Capitalize on these analyses to propose actions for improvement or prevention:
a) 工藝流程和/或者系統(tǒng)替代裝配、啟動、功能或生物測試、包裝。Processes and/or systems in place for assembly, starting up, functional or biological tests, packaging or wrapping.
b) 從供應(yīng)商收到的部件。Components received from suppliers.
- 建立必要的KPI來衡量生產(chǎn)的產(chǎn)品質(zhì)量。Establish the KPIs necessary to measure the quality produced by the production site.
- 解決分配給生產(chǎn)部門的客戶投訴。Supervise the resolution of customer complaints assigned to Production.
2. 與法國STAGO配合管理儀器的工業(yè)化生產(chǎn)。Supervise the industrialisation of the instruments in collaboration with STAGO France
- 在法國STAGO的管理下，維護(hù)最新的儀器物料清單(零件清單和數(shù)量)。Maintain up‐to‐date instrument Bill of Materials (parts list and quantities) under the supervision of STAGO France.
- 管理有法國STAGO來的生產(chǎn)范圍轉(zhuǎn)移：Supervise the transfer of production ranges from STAGO France to :
a) 來料檢驗(yàn)Incoming inspection
b) 儀器裝配Assembly of Instruments
c) 儀器啟動Starting up of Instruments
d) 功能和生物測試Functional and biological tests
e) 成品包裝Product package
- 管理任何儀器設(shè)計(jì)變更的部署。Oversee the deployment of any instrument design changes.
- 通過適用的程序、流程和說明，管理任何偏差的部署。Oversee the deployment of any deviations through applicable procedures, processes and instructions.
- 管理生產(chǎn)所需的工具。Ensure the management of the tooling required for production.
- 必要時(shí)，協(xié)調(diào)裝配車間技術(shù)人員和分包商的培訓(xùn)。Coordinate the training of technicians in the assembly workshop and any subcontractors whenever necessary.
- 為采購和/或供應(yīng)鏈部門在本地供應(yīng)商和部件的選擇和認(rèn)證過程中提供所有必要的支持。Provide all necessary support to the Purchasing and/or Supply departments in the selection and qualification processes of locally sourced suppliers and components.
3. 確保在質(zhì)量體系框架內(nèi)改進(jìn)儀器制造工藝及其可靠性。To ensure the improvement of instrument manufacturing processes and their reliability within the framework of the quality system.
- 參與分析儀器裝配操作，并實(shí)施解決方案以提高生產(chǎn)率和提高工作條件(人體工程學(xué)，工裝，必要的自動化等)。Participate in the analysis of instrument assembly operations and in the implementation of solutions to improve productivity and working conditions (ergonomics, tooling, necessary automation, etc.).
- 參與生產(chǎn)工具和儀器的工業(yè)化生產(chǎn)。Participate in the industrialization of instruments and means of production.
- 確保與部門/活動相關(guān)的質(zhì)量程序的發(fā)布。Ensure the release of quality procedures relating to the department / activities.
- 確保技術(shù)問題和不符合項(xiàng)的解決，報(bào)告應(yīng)用中的任何錯誤/困難，并提出必要的修改建議。Ensure the resolution of technical problems and non‐conformities, report any errors/difficulties in their application and propose the necessary modifications.
- 確保公司實(shí)施有效的規(guī)章制度:GMP(醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范)，質(zhì)量，規(guī)章制度，程序，指令和操作模式，內(nèi)部規(guī)章制度，健康和安全指令。Ensure the application of the rules in force in the company: GMP (Good Manufacturing Practices), quality, regulations, procedures, instructions and operating modes, internal regulations, health and safety instructions.
- 確保對質(zhì)量體系的理解和遵循。Ensure understanding and compliant application of the quality system.
核心能力
1． 了解醫(yī)療器械相關(guān)法律法規(guī)，具有較強(qiáng)的質(zhì)量意識。Understand the relevant laws and regulations of medical devices, and have strong quality awareness.
2． 具有醫(yī)療器械生產(chǎn)裝配等工作能力。Has the ability to assemble medical device
3． 能夠進(jìn)行流暢的英語書寫和口語表達(dá)。Fluent English in writing and spoken.
4． 嚴(yán)謹(jǐn)、有活力、踏實(shí)、敏捷、細(xì)心并且積極主動、有責(zé)任心。Rigorous, dynamic, practical, agile, careful, proactive and responsible.
5． 較強(qiáng)的學(xué)習(xí)能力，動手操作能力強(qiáng)。Strong ability in learning ,and Strong hands-on skills
6． 具有較強(qiáng)的溝通能力及團(tuán)隊(duì)協(xié)作精神。Strong communication skills and team spirit
工作經(jīng)驗(yàn)
3年以上醫(yī)療器械或電子工廠裝配及測試等相關(guān)工作經(jīng)驗(yàn)，熟悉裝配及測試等工藝流程
Stago fosters an inclusive and respectful work environment.
Stago致力于營造包容、尊重他人的工作環(huán)境。