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Key Responsibilities:
1.Ensure compliance with EHS regulations, promoting a safe and sustainable working environment for all employees.
確保符合環(huán)境、健康與安全（EHS）法規(guī)要求，為所有員工營(yíng)造安全、可持續(xù)的工作環(huán)境。
2.Develop and implement manufacturing strategies and processed to optimize productivity and reduce the cost.
制定并實(shí)施制造戰(zhàn)略和工藝流程，以?xún)?yōu)化生產(chǎn)效率并降低成本。
3.Monitor and analyze production metrics to identify improvement area and implement corrective actions.
監(jiān)控并分析生產(chǎn)指標(biāo)，識(shí)別改進(jìn)領(lǐng)域并落實(shí)糾正措施。
4.Ensure all products meet the quality expectations of ISO 13485 standard.
確保所有產(chǎn)品符合ISO 13485標(biāo)準(zhǔn)的品質(zhì)要求。
5.Lead, mentor and develop a high-performing MFG team, fostering a culture of collaboration , accountability and continuous improvement.
6.Develop budget, capex investment plan, long-term and short term planning processes.
領(lǐng)導(dǎo)、指導(dǎo)并打造高效制造團(tuán)隊(duì)，營(yíng)造協(xié)作、責(zé)任擔(dān)當(dāng)與持續(xù)改進(jìn)的文化。
制定預(yù)算、資本支出投資計(jì)劃及長(zhǎng)短期規(guī)劃流程。
7.Lead the cross-function team to work on developing and implement new process and new manufacturing technology to enhance manufacturing capabilities.
領(lǐng)導(dǎo)跨職能團(tuán)隊(duì)，開(kāi)發(fā)并實(shí)施新工藝及制造技術(shù)，提升生產(chǎn)能力。
8.Drive the process improvement to result in a continuous productivity increase and cost reduction.
推動(dòng)工藝改進(jìn)，實(shí)現(xiàn)持續(xù)增效降本。
9.Very familiar with the key QMS processes including:
Engineering change
DMR
DHR
CAPA
Verification and Validation
Nonconformance management
Supplier quality management
精通以下關(guān)鍵質(zhì)量管理體系（QMS）流程：
工程變更（Engineering Change）
醫(yī)療器械主記錄（DMR, Device Master Record）
設(shè)備歷史記錄（DHR, Device History Record）
糾正與預(yù)防措施（CAPA, Corrective and Preventive Action）
驗(yàn)證與確認(rèn)（Verification and Validation）
不合格品管理（Nonconformance Management）
供應(yīng)商質(zhì)量管理（Supplier Quality Management）
Required Qualifications:
Education:
1.Bachelor's degree in Engineering, Electronic , Mechanical, or a related technical field.
2.Master’s degree preferred.
教育背景：工程、電子、機(jī)械或相關(guān)技術(shù)領(lǐng)域本科學(xué)歷。碩士學(xué)歷優(yōu)先。
Professional Experience:
1.At least 10 years of experience in operation manager or manufacturing manager or production manager roles in the medical device industry with an international context.
至少10年在國(guó)際化醫(yī)療器械企業(yè)擔(dān)任運(yùn)營(yíng)經(jīng)理、制造經(jīng)理或生產(chǎn)經(jīng)理職位的經(jīng)驗(yàn)。
2.Proven track record of ISO 13485 or FDA 21 CFR Part 820 QMS implementation or oversight.
具備ISO 13485或FDA 21 CFR Part 820質(zhì)量管理體系（QMS）實(shí)施或監(jiān)管的成功經(jīng)驗(yàn)。
3.In-depth knowledge of:
Lean manufacturing /production
ISO 13485
Products/Projects transferring cross countries
ERP
深入掌握以下領(lǐng)域知識(shí)：
精益生產(chǎn)（Lean Manufacturing/Production）
ISO 13485標(biāo)準(zhǔn)
跨國(guó)產(chǎn)品/項(xiàng)目轉(zhuǎn)移（Products/Projects Transferring Cross Countries）
企業(yè)資源計(jì)劃（ERP）系統(tǒng)
Certifications (preferred):
ISO 13485 Lead Auditor
Lean manufacturing related certification
資質(zhì)認(rèn)證（優(yōu)先考慮）：
ISO 13485 主任審核員（Lead Auditor）
精益生產(chǎn)相關(guān)認(rèn)證（Lean Manufacturing Certification）
Language Proficiency:
1.Excellent written and spoken English is required.
優(yōu)秀的英語(yǔ)書(shū)面及口語(yǔ)能力。
2.Must be capable of writing precise technical documents and effectively communicating with auditors, regulators, and global teams.
能夠撰寫(xiě)精準(zhǔn)的技術(shù)文件，并與審核員、監(jiān)管機(jī)構(gòu)及全球團(tuán)隊(duì)高效溝通。