瑞健股份有限公司

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems for the past 30 years with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland with sites in Sweden, Taiwan, and the Unites States. [Job Overview] This position is a senior technical role in the Metrology Method Development group within our Global Process Development team in Taiwan. [Your responsibilities] · Develop new measurement methods for both engineering studies and mass production quality control from Design for Manufacturing (DFM) to implementation · Work cross-functionally, closely collaborate with engineers, QA/RA specialists, product management, and external contributors for project execution · Communicate detailed progress updates within cross-functional meetings · Lead investigation and improvement for the performance of existing solutions experimentally and theoretically · Structure and be responsible for corresponding work packages and, if necessary, sub-projects · Document results and present them internally as well as to customers and international development partners as needed · Laying the groundwork towards a digital twin · Other duties may be assigned · 從工程開發到量產測量方法開發 ，考量範圍包含DFM到實際執行 · 藉由跨部門合作，與工程師、品質及法規部門、產品管理單位...等密切合作，以確保專案時程順利推進 · 在跨部門溝通會議中詳細並有效地進行溝通 · 通過實驗和理論研究，領導調查和改進。 · 將專案及接續有關的子專案結構化，並記錄結果，根據需求給予內部相關單位及外部客戶。 [Your qualification] · An above-average university degree in physics, mathematics or engineering · Minimum 3 years of relevant industry experience in engineering · Experience in the development of measurement and adjustment methods highly preferred · Experience in CMM and/or CT scanning highly preferred · Experience and knowledge in Metrology (e.g. MSA) and statistic with Minitab preferred · Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus · Analytical thinking and a high level of comprehension as well as problem solving skills · Equal ability to work effectively as an individual on one’s own initiative and as part of a team in a multi-cultural and multi-disciplinarily environment. · Strong report writing and communication skills (written & verbal) in English and Mandarin · 具備物理、數學或工程學相關之學士學位(或以上) · 至少3年相關工程領域之經驗 · 有測量和調整方法開發經驗者優先考慮 · 具有CMM和/或CT掃描經驗者優先考慮 · 具有量測技術（例如MSA）和統計學知識(Minitab)優先考慮 · 具醫療、製藥相關標準知識（例如ISO13485、cGMP）者為佳 · 具有分析思維、高度理解力以及解決問題能力 · 具有跨文化和跨領域環境中獨立工作, 主動積極, 團隊合作的能力 · 具有撰寫中英文報告及良好溝通能力

Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請： https://www.shl-medical.com/careers/jobs-at-shl-medical/it-server-engineer 【Job Overview】 In Taiwan, SHL Medical is looking for a Senior Server Engineer as part of the Information Communication Technology Infrastructure team. The responsibility of the Senior Server Engineer comprises the management and maintenance of business-critical Windows and Linux server infrastructure. The position cooperates closely with consultants, vendors, IT, Security, and business stakeholders. Together with system owners and architects, the Senior Server Engineer plans, proposes, and provisions technical solutions that meet technical best practices and the company’s business goals. SHL Medical 正在尋找一名資深伺服器工程師加入IT Infra團隊。資深伺服器工程師的職責包括管理和維護關鍵業務的 Windows 和 Linux 伺服器基礎設施。此職位需與顧問、供應商、IT、安全部門及業務相關方密切合作。資深伺服器工程師將與系統擁有者和架構師共同計劃、提案並提供符合技術最佳實踐和公司業務目標的技術解決方案。 【Responsibilities】 ‧ Act as 2nd support line to help on solving users’ issues in concern of server infrastructures and fulfil the SLA ‧ Design, implement, maintain and improve server infrastructures such as ‧ Microsoft environments, Linux Servers (SUSE Enterprise, Ubuntu LTS), SAN storage, rack-mount/blade servers, backup solution, VMware server virtualization, IaaS solution (Azure) and infrastructure monitoring solution ‧ Lead troubleshooting and root cause analysis to effectively resolve issues and deliver sustainable solutions in collaboration with technical peers ‧ Monitor server infrastructure health and keep track of their availability, performance, and responsiveness ‧ Work closely together with the Information Security organization to enhance and improve security setups for server infrastructures ‧ Write the documentation of design specifications and implementation details ‧ 作為第二線支持，協助解決用戶關於伺服器基礎設施的問題並達成服務水平協議 (SLA) ‧ 設計、實施、維護並改進伺服器基礎設施，如 Microsoft 環境、Linux 伺服器 (SUSE Enterprise、Ubuntu LTS)、SAN 存儲、機架式/刀片伺服器、備份解決方案、VMware 伺服器虛擬化、IaaS 解決方案 (Azure) 和基礎設施監控解決方案 ‧ 領導故障排除和根本原因分析，與技術同行合作，有效解決問題並提供可持續的解決方案 ‧ 監控伺服器基礎設施的健康狀況，跟踪其可用性、性能和響應速度 ‧ 與信息安全組織緊密合作，增強和改進伺服器基礎設施的安全設置 ‧ 編寫設計規格和實施細節的文檔 【Qualification】 ‧ University degree, ideally in Computer Science or Information Systems ‧ 5+ Years of server infrastructure-related experience in the following technologies: ‧ Microsoft Active Directory domain services, Hybrid AD setup with On-Prem AD and Entra ID related features, Windows Servers (2012 R2 to latest versions), Windows clustering or related high-availability technologies, Azure services ‧ Backup solution ‧ File and print services using Windows Server ‧ SAN Storage and NAS (FC-SAN, iSCSI, NAS appliances) ‧ VMware server virtualization ‧ Strong knowledge in Windows server performance analysis, including use of performance monitor or related tools to identify bottlenecks or resource issues ‧ Strong Knowledge of Windows networking technologies and use of diagnostic tools such as Wireshark or Network Monitor to identify communication issues ‧ Strong Knowledge of Active Directory architecture, monitoring, and troubleshooting. Accessing and securing network resources via NTLM, Kerberos and SSL knowledge in DR site implementation (hot site or warm site) ‧ Familiar with Microsoft Azure services ‧ Familiar with PowerShell scripts in automating operational processes ‧ 大學學位，資訊科學或資訊系統相關領域為佳。 ‧ 5年以上伺服器基礎架構相關經驗，涵蓋以下技術： ‧ Microsoft Active Directory 網域服務，包括本地 AD 與 Entra ID 的混合 AD 設定及相關功能。 ‧ Windows Server（2012 R2 至最新版本）。 ‧ Windows 群集或相關高可用性技術。 ‧ Azure 雲端服務。 ‧ 備份解決方案。 ‧ 使用 Windows Server 的檔案與列印服務。 ‧ SAN 儲存與 NAS 技術（如 FC-SAN、iSCSI、NAS 應用裝置）。 ‧ VMware 伺服器虛擬化技術。 ‧ 熟悉 Windows 伺服器效能分析，能使用效能監視器或相關工具來識別瓶頸或資源問題。 ‧ 精通 Windows 網路技術，並能使用 Wireshark 或 Network Monitor 等診斷工具排除通訊問題。 ‧ 深入了解 Active Directory 架構，包括監控與故障排除。熟悉 NTLM、Kerberos 和 SSL 驗證以存取及保護網路資源，並具備災備中心（熱備份或溫備份）實施經驗。 ‧ 熟悉 Microsoft Azure 服務。 ‧ 熟悉使用 PowerShell 腳本進行操作流程自動化。

***【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】*** https://www.shl-medical.com/careers/jobs-at-shl-medical/qe-senior-process-quality-engineer-assembly-automation 有別於常聽的到Quality Assurance(QA)和Quality Control(QC)是接近量產階段的部門，我們的Quality Engineering (QE)部門是屬於前端研發團隊中的一環。最重要的使命和任務就是，希望能大量減少產品走到量產的階段才發現問題來進行補救，而是在開發設計階段就針對品質去把關。 在醫療器材產業中，品質絕對是擺在第一位！2025年部門持續擴大招募中，歡迎所有對於堅守產品品質有興趣的工程背景人選。 【Job Overview】 The Process Quality Engineer (Assembly & Automation) is responsible for supporting new process development, automation equipment development and product transfer through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product/process inception through product launch, scale-up, deployment and retrofit, and play an active role in the processes to ensure products meet quality standards consistent with Customer Requirement, while meeting all design control and other regulatory requirements, including, but not limited to FDA Quality System Regulation 21 CFR Part 820, 21 CFR Part11, ISO 13485, ISO 11608 & ISO 14971. 【Main Responsibilities】 • Represents Quality on process design, equipment development, and product transfer projects through Product Lifecycle. • Ensures that all design control and process/production control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements. • Assesses failure modes and approves the risk mitigation tool, techniques, good practices to ensure the risk management processes are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – DFMEA, PFMEA, and other risk assessment in system level. • Practices Quality Function Deployment (QFD) method to evaluate control action from Customer, Design, to Process-wise. • Promotes the use of statistics in the pre-study, engineering investigation, and in-process control based on quality aspects. • Supports Device product/process development and product transfer activities, including the following: • Consolidates or reviews lessons learned and historical data to influence product design. • Supports or reviews process/equipment specifications and requirements including system level. • Supports or reviews process/equipment verifications activity (protocols and reports) and validation/test plans. • Participates in product or process/equipment design and change activities, including qualification and reviews. • Participates in risk management activities including review failure mode effects analysis (FMEA) and/or risk or statistical analysis. • Provides technical support for product and process quality attributes/decisions. • Support selected qualification activities (e.g., advanced inspection performance check, sterilization validation, etc.) with external suppliers. • Contributes to compilation and maintenance of Design History Files (DHF). • Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System.

This position does not accept applications via 104. Please submit your application on the SHL Career Website: https://www.shl-medical.com/careers/jobs/project-management-project-manager SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems for the past 30 years with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland with sites in Sweden, Taiwan, and the Unites States. 【Job Overview】 A dedicated and experienced Project Manager with strong technical background, attention to detail and a background in product development and industrialization in the medical device or pharma industry. 【Main Responsibilities】 。Lead new product introduction projects with a multi-disciplinary team of highly skilled experts. 。Plan and manage all aspects of the project life cycle (design, engineering, tech transfer, validation, launch, scale-up). 。Establish and maintain appropriate structures to ensure communication, flow of information and documentation within the project. 。Responsible for project deliverable, schedule, cost and quality as well as reporting directly to relevant stakeholders within the organization. 。Cross-functional role with strong interaction with various departments, internal stakeholders, suppliers and customers. 。Ensuring effective implementation of requirements enabling fast ramp up of production and benefit realization. 【Required Skills & Qualifications】 。Degree in Engineering or Applied Sciences is preferred. 。5+ years of relevant industry experience in product development, NPI, industrialization, scale-up and high-volume production. 。Project management experience in highly complex areas with numerous stakeholders; proficient in corresponding PM methodologies and tools. 。Experience with plastic injection molding, tooling and automated assembly processes would be a plus. 。Experience in one or more of the following areas: GMP production / medical device quality systems (i.e. ISO13485, GMP, FDA CFR21) / supply chain management / contract manufacturing. 。Combination product experience is an asset. 。Six Sigma experience preferred. 。Strong intercultural and interdisciplinary communication skills; excellent written and verbal English. 。Experience in international collaboration programs and good at building professional networks 。Able to work under pressure to achieve short-term targets without compromising long-term objectives. 。Capable of handling communication and cooperation with stakeholders over distance. 【We offer】 。Modern & variety of culture working environment with state-of-the-art facilities and technologies. 。Challenging assignments in a fast growing and innovative industry. 。Position in a dynamic, international team of highly skilled professionals. 。Various opportunities for personal and professional development within a global organisation. 。Flexible working hours and WFM policy.

【Job Overview】 The Assembly Process Validation Engineer is responsible for defining validation strategy and executing/coordinating validation activities required to launch new automation assembly equipment or assembly process into the production environment. The successful candidate will perform validation activities that include Assembly Equipment Qualification, and Process Validation of an integrated manufacturing system. Work with a cross functional team to introduce new manufacturing equipment, new process, or new technology to mass production. 【Main Responsibilities】 • Validate new assembly equipment and/or processes in collaboration with a diverse functional engineering team. • Generate and sustain Verification/Validation protocols/reports (IQ, OQ, PQ, PV) and related technical documents to support the transfer of assembly equipment/process from development into mass production. • Provide technical assessment and validation review/approval for changes regarding manufacturing equipment, assembly process and related standard operating procedures. • Participate in design, development, commissioning, and qualification of automated manufacturing equipment. • Assist in failure investigations and root cause analyses occurred during equipment qualification and process validation. • Involve in the risk assessment (P-FMEA) of manufacturing equipment/process and provide input to the risk mitigation plan as validation engineer. • Involve in internal and external audits. 【We offer】 • Modern & variety of culture working environment with state-of-the-art facilities and technologies. • Challenging assignments in a fast growing and innovative industry. • Position in a dynamic, international team of highly skilled professionals. • Various opportunities for personal and professional development within a global organization. 【工作概述】 組裝製程驗證工程師負責定義驗證策略並執行/協調驗證活動，以將新的自動化組裝設備或組裝製程導入生產線。成功的候選人將執行包括組裝設備確認和公司整體製造系統的製程確效在內的相關驗證活動。此工作將與跨職能團隊合作，導入新的製造設備、新製程或新技術至量產階段。 【主要職責】 • 與各職能工程團隊合作，驗證新的組裝設備、製程和/或設計。 • 撰寫和維護驗證/報告（IQ, OQ, PQ, PV）和相關技術文件，以支持將組裝設備/製程從開發階段轉移到量產階段。 • 就製造設備、組裝製造流程及相關標準操作程序的變更提供技術評估和驗證審查/批准。 • 參與自動化製造設備/機器的設計、開發、調機和驗證。 • 協助設備驗證或製程確效期間發生的相關的偏差調查和根本原因分析。 • 參與製造設備/製程的風險評估（P-FMEA），並作為驗證工程師向風險緩解計劃提供意見。 • 參與內部和外部稽核。 【我們提供】 • 現代且擁有先進的設施和技術的工作環境，多樣化的文化。 • 在快速成長和創新的行業中挑戰高難度的任務。 • 在一個充滿活力的國際團隊中擔任職位，與技能卓越的專業人士共事。 • 全球組織中有各種個人和職涯發展的機會。

****【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】：https://www.shl-medical.com/careers/jobs/oe-senior-project-manager-operations SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems for the past 30 years with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Factory Development & Projects group within our Global Operations Engineering team in Taiwan. Your responsibilities · Lead and manage challenging Industrialization, Infrastructure/Site development and technology transfer projects in Operations · Plan and manage production scale-up and capacity deployment projects as well as related product care initiatives in Operations · Develop concept studies and strategic decision proposals to senior management · Responsible for project planning, deliverables, schedule, cost and quality as well as management reporting · Establish and maintain appropriate structures to ensure communication, flow of information and documentation within the project · Cross-functional leader role interacting with senior management, various departments, internal stakeholders and clients · Ensuring effective change management and implementation of site infrastructure enabling fast and sustained ramp-up of production and benefit realization Your qualification · Degree in Engineering or Applied Sciences · Minimum 6 years relevant industry experience in Operations/Logistics, Manufacturing, Production Scale-up, Technology transfer or Facility/Construction management · Project management and leadership experience in highly complex projects with numerous stakeholders; proficient in state-of-the-art PM methodologies and tools · Experience in one or more of the following areas: manufacturing infrastructure and site development / intralogistics / supply chain management / contract manufacturing / technology transfer / injection molding, process automation · Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus · Lean / Six Sigma experience is a plus · Strong intercultural and interdisciplinary communication skills; excellent written and verbal English · Self-starter and fast learner, able to deal with ambiguity in a complex, dynamic and changing environment. · Able to work under pressure to achieve short-term targets without compromising long-term objectives

【Job Overview】 This role is embedded in the Factory Development & Projects Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 • Together with the rest of your team you will support the development, improvement and implementation of highly automated material handling and logistics systems • Develop equipment specifications and requirements based on product constraints / Provide design layouts and equipment solutions / Conduct equipment design reviews and provide design guidance to vendors. • Improve systems & equipment reliability for the core processes to meet all customer, business & regulatory requirements • Collaborate closely with shopfloor production technicians, equipment builders and maintenance, quality and process development on performance/process improvements and troubleshooting. • Lead improvement initiatives and capacity deployment across multiple production processes. • Design review and optimization of site layouts for production, material flow, construction, and facilities. • Support integration of systems and processes into our global digital landscape (EWM, EAM, MES, …) 【We offer】 • Competitive compensation package • Flexible hours and working from home policy. • Modern working environment with state-of-the-art facilities and technologies • Challenging assignments in a fast growing and innovative industry • Position in a dynamic, international team of highly skilled professionals • Various opportunities for personal and professional development within a global organization

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland, SHL has sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Packaging & Forming Technology Team within our Operations Engineering Department in Taiwan. 【Your responsibilities】 ● Together with the rest of your team you will support the production of packaging material and component printing processes for our autoinjector systems ● Lead engineering responsibility for packaging production lines and printing processes within our production system ● Collaborate closely with shop floor production technicians, maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future packaging and printing concepts ● Lead improvement initiatives and capacity deployment in packaging and printing ● Responsible for manufacturing acceptance of new packaging and printing processes in regular production ● Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products 【We offer】 ● Competitive compensation package ● Flexible hours and working from home policy ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization

****【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】：https://www.shl-medical.com/careers/jobs/oe-senior-manufacturing-engineer-assembly-process-equipment This role is embedded in the Automation Technology Team within Operations Engineering Department in Taiwan. 【Your responsibilities】 • Lead and support troubleshooting and issue resolution of critical production equipment to minimize unplanned downtime. • Provide mechanical leadership and support for the rest of the department • Improve system and equipment reliability for the core processes to meet all customer, business, and regulatory requirements. • Lead the development of equipment improvement plans, including proposing new designs and retrofits, getting stakeholder buy-in, working with relevant vendors, and managing implementation & testing. • Lead and support commissioning and acceptance testing of new production equipment. • Manage technology transfer (receiver function) of new equipment into mass production. • Support validation activities for new equipment and processes as necessary • Lead and support the identification of novel production equipment for next-gen manufacturing systems. • Promote the use of new technologies and industry-leading trends. Provide the highest level of technical expertise. • Collaborate closely with production teams, machine builders, process/product development groups, and the quality department on performance/process improvements, troubleshooting, and critical event response. 【Your qualification】 ● Degree in Engineering or equivalent education/experience in a relevant field ● Several years of relevant hands-on manufacturing experience with highly automated high-volume production systems ● Familiar with Siemens PLC based systems, sensor, actuator and vision technologies, SCADA ● Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams ● Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies; Six Sigma certification is a plus. ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost ● Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written)

****【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請：https://www.shl-medical.com/careers/jobs/oe-manufacturing-process-engineer-molding-technology 【Job Overview】 This role is embedded in the Molding Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 • Together with the rest of your team you will support the production of injection molded components for our autoinjector systems. • Collaborate closely with shopfloor production technicians, tool makers and maintenance, quality and process development on performance/process improvements and trouble shooting. • Lead the development of improvement plans and requirements for capacity expansion and future mold generations and production setups. • Lead cross-functional Root Cause Analysis and Event Response Investigations. • Lead cross-functional improvement projects and capacity deployment projects. • Coordinate manufacturing acceptance of new molds and process in regular production. • Coordinate Design for Manufacturing (DFM) assessments and definition of manufacturing requirements for new products. 【Your qualification】 • Degree in Mechanical Engineering, Polymer Science or similar education/experience • Several years of relevant industry experience in manufacturing / injection molding / mold making / product industrialization • Knowledge of relevant polymer processing technologies. • Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies and their application. • Excellent project management skills • Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost • Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done • Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) • Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus • Ability to communicate in Mandarin is highly desirable

【關於瑞健】 瑞健醫療 ( SHL Medical ) 為領航全球的藥物輸送解決方案供應商， 在設計、研發及製造先進藥物輸送系統上居龍頭地位， 產品含括自動注射器、筆型注射器與穿戴式藥物輸送系統等。 【工作內容】 • 數量的盤點、記帳 • 零件的收料、備料以及拉料 (油壓車) • 使用物流系統投入生產工單所需要的所有物料。 • 生產事情作業排成 • 協助物料專員執行盤點作業活動 • 完成主管交辦有關生產產品、程序事宜 【人才需求】 • 一年以上製造行業工作經驗佳 • 12小時，4休3制（早班 0800-2000 / 夜班2000-0800 / 輪班 2-3月輪一次） • 數字觀念清楚、細心度佳 • 視力及辨色力正常（裸視 0.6以上 / 矯正後視力 0.8以上） *薪資不含津貼與獎金，加班另計* 津貼/獎金/加班費 發放方式依公司規定辦理

【若您有興趣，請至此網站投遞職缺】 https://careers.shl-medical.com/job/MFMG-Molding-Manufacturing-Operator/438-zh_TW/ 【工作內容】 • 進行製造現場的產品組裝、檢驗、包裝出貨等作業（大約5-10公斤） • 填寫生產報表，以檢視與生產目標的距離 • 完成主管交辦有關生產產品、程序事宜 【人才需求】 • 12小時，4休3制（日班 0800-2000 / 夜班2000-0800） (兩種班制選擇: 固定日班或是輪班，二到三個月輪一次） • 數字觀念清楚、細心度佳 • 視力及辨色力正常（裸視 0.6以上 / 矯正後視力 0.8以上）

【About Company】 SHL Medical is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018. Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine. 【Department Introduction】 Supply Chain at SHL Medical consists of five teams, including demand relations&planning, procurement, logistics, shipping and intelligence. We have to fulfill the demand from customers through building a robust supply chain with attention to customer and supplier relationships through all value chain. 【Job Overview】 Develop and implement a worldwide and integrated supply chain and logistics strategy to facilitate the cost-effective flow of merchandise from suppliers to customers. 【Main Responsibilities】 船務、關務執掌: 1. 出口船務、關務作業安排及審查。 2. 按不同國家需求申請並製作出口所需文件，以利國外客戶順利通關。 3. 空運出貨作業安排，包含訂艙、出口文件製作、貨代與報關行的聯繫作業。 4. 出貨資料登錄及各項應付帳款事宜。 5. 協調完成國內外業務的出貨需求。 6. 處理業務或從國外客戶有關物流及關務問題之詢問解答及英文書信往來。 7. 運費價格的審查與議價。 8. SAP系統的應收帳款與銷貨折讓處理。 【Required Skills & Qualifications】 1. 船務、關務經驗: 3年以上 2. 英文標準:多益785以上 3. 具備良好辦公室軟體操作能力(word/excel) 4. 有ERP(SAP)系統操作經驗尤佳 5. 具備團隊合作精神、學習意願高

Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請： https://www.shl-medical.com/careers/jobs-at-shl-medical/it-services-engineer 【Job Overview】 SHL Medical 正在尋找一名資訊工程師加入資訊台灣資訊團隊。資訊工程師的職責包括管理和維護 Microsoft Windows 客戶端基礎設施。此職位需與終端用戶、供應商、IT、安全部門以及業務相關方密切合作。資訊工程師將與業務用戶和系統擁有者共同計劃、提案並提供符合技術最佳實踐和公司業務目標的客戶端技術解決方案。 【Main Responsibilities】 1. Service Delivery and Process Adherence 服務交付和流程遵循 ‧ Strictly adhere to all applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs) ‧ Implement and maintain IT Service Management (ITSM) best practices and Good Manufacturing Practices (GMP) ‧ 確實遵守所有適用的標準作業程序(SOP)和工作說明書(WI) ‧ 落實並執行IT服務管理(ITSM)最佳實務做法和優良製造規範(GMP) 2. Incident Management and Service Request Fulfillment事件管理和服務請求履行 ‧ Serve as the primary point of contact for the Servics, handling all incidents and service requests across the organization. ‧ Provide comprehensive IT support through multiple channels (phone, ITSM portal, walk-in) ‧ Deliver remote troubleshooting and phone-based technical consultation services ‧ Manage tickets in the ITSM system according to defined Service Level Agreements (SLAs) ‧ Assess the nature, impact, and urgency of incidents, escalating to Level 2 (L2), Level 3 (L3) support, or Subject Matter Experts (SMEs) when necessary ‧ Investigate user requirements, collaborating with L2/L3 engineers and SMEs to ensure needs are met ‧ 擔任 IT Services 第一線窗口，負責接收和處理所有事件(Incident)和服務需求(Service Request) ‧ 透過多元管道(電話、ITSM系統、現場支援)提供全方位的IT支援服務 ‧ 提供遠端故障排除和電話技術諮詢服務 ‧ 依據服務等級協議(SLA)在ITSM系統中管理工單(Ticket) ‧ 評估事件的性質、影響範圍和急迫性，必要時將問題向上升級(Escalate)至二線(L2)、三線(L3)支援或專業技術人員(SME) ‧ 調查使用者需求，與L2/L3工程師和SME合作，確保需求獲得滿足 3. Knowledge Management and Continuous Improvement知識管理和持續改進 ‧ Collaborate with SMEs to develop and update the First Level Resolution (FLR) knowledge base ‧ Strive to improve First Contact Resolution (FCR) rate and optimize problem-solving efficiency ‧ 與SME合作開發和更新第一線解決方案(FLR)知識庫 ‧ 致力提高首次聯繫解決率(FCR)，提升問題解決效率 4. IT Asset Management IT資產管理 ‧ Establish and update standards for IT equipment allocation ‧ Maintain accuracy of asset status within the ITSM system ‧ Assign IT assets based on user requirements and Work Instruction ‧ 制定和更新使用者資產使用與配發標準 ‧ 維護ITSM系統中資產狀態的正確性 ‧ 依據使用者需求和內部標準分配IT資產 5. System Maintenance and Updates系統維護和更新 ‧ Execute routine updates and maintenance for endpoints according to schedules and plans ‧ 按計畫執行終端設備(Endpoint)的例行更新和維護 【Required Skills & Qualifications】 ‧ Knowledge in Windows client performance analysis, including use of performance monitor or related tools to identify bottlenecks or resource issues ‧ A high level of autonomy in combination with a results-driven mindset ‧ Not afraid to speak English, and willing to work in a foreign company environment. ‧ 了解Windows客戶端性能分析，包括使用性能監控器或相關工具識別瓶頸或資源問題 ‧ 具有高度的自主性，並具有以結果為導向的心態 ‧ 不害怕說英文，願意在外商環境中工作

1. 門禁管制及車輛進出指揮。 2. 訪客進出登記及換證。 3. 訪客拜訪通知相關單位及引導。 4. 注意公司門面確保乾淨整潔。 5. 廠區巡視維護廠區安全。 6. 夜間監看監視器畫面留意可疑及回報。 7. 確保廠區安全公共安全，避免火災、竊盜及其他危害。 8. 其他臨時主管交辦事項。

1.廠區清潔維護、備品補充。 　　 2.清潔機具設備操作。 3.依據公司管理系統、規範、班表，執行清潔作業。 4.VIP室暨公寓清潔維護。 5.其他主管交待工作事項。 6.須配合，隔周六加班

****【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】：https://www.shl-medical.com/careers/jobs/ci-continuous-improvement-engineer Job Overview The role will work with different business functions within the organization to improve manufacturing and operations processes using lean methodology concepts and other improvement tools. Lead and support CI programs and lean transformation to promote lean culture & work safety, improve quality & efficiency, and achieve a world-class lean manufacturing facility. The role must also help to identify & analyze improvement opportunities to have a clear visibility of benefits that will rationalize the management approval and execution. The role may also require leading, managing, and/or supporting medium-scale cross-functional projects that are align to site goals, operational excellence initiatives, and best practices. Educate and train employees to effectively use the CI tools to support company growth, scale-up, and achieve the business goal. This also includes facilitation of some CI related activities and workshops. Responsibilities: • Facilitate and drives Continuous Improvement program to promote lean culture. • Coach and mentor Lean Champions to become an independent driver and promoter of continuous improvement of their department. • Spearheads cost-saving initiative’s justification in line with identified Lean/CI projects. • Supports the achievement of set performance objectives (KPIs) for the workstream. Proposes action plans in collaboration with the Lean Champion. • Focuses on business performance that constantly strives to eliminate waste & improve customer satisfaction with lean tools and methodologies. • Conduct process analysis and being able to simulate or build models of processes, carrying out VSM (Value Stream Mapping) and guide the implementation of e.g., SMED, Visual management, Kanban/Pull system, Kaizen, 6S, routine Gemba Walk, etc. • Train and educate employees with Lean tools and techniques in line with the CI training program to be able to promote Lean culture. • Transform company culture with a strong focus on lean processes and best 6S practices. • Responsible for planning and assisting in the execution of various Lean/CI activities aimed at improving the business’s performance on safety, quality, delivery, and cost. • Adheres to established Quality Policy, GMP, and EHS rules. • Promotes SHL culture strategies and values. • Undertakes other duties as appropriate within his/her competence, as required by superior from time to time. Qualifications: • Graduate of Degree in Industrial Engineering or related field or equivalent experience. • Minimum of 5-year experience in a lean or high-volume manufacturing facility as Process / Industrial / Lean/CI Engineer. • Analytical and capable of performing analysis for any type of information/data using descriptive and enumerative statistical methods • Ability to utilize Lean and/or Continuous improvement tools to generate meaningful and quantified improvement • Proficient in the use of computer programs such as office applications and statistical analysis software e.g., PowerPoint, Excel, Word, Minitab, etc. • Good command in English communication skills, both in speaking and writing; and experienced on technical report writing. Technical Skills: Lean Six Sigma Methodology, Project Management, Process Improvement, Change Management, Technical Writing, Training/Workshop Facilitation, MS Office Applications (Excel, Word, PowerPoint)

***【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】*** https://www.shl-medical.com/careers/jobs-at-shl-medical/qe-senior-process-quality-engineer-molding-tooling 有別於常聽的到Quality Assurance(QA)和Quality Control(QC)是接近量產階段的部門，我們的Quality Engineering (QE)部門是屬於前端研發團隊中的一環。最重要的使命和任務就是，希望能大量減少產品走到量產的階段才發現問題來進行補救，而是在開發設計階段就針對品質去把關。 在醫療器材產業中，品質絕對是擺在第一位！2025年部門持續擴大招募中，歡迎所有對於堅守產品品質有興趣的工程背景人選。 【Job Overview】 The Quality Engineer of Process - Molding&Tooling is responsible for supporting new product development, process development and product care through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product/process inception through product launch, scale-up and maintenance and play an active role in the processes to ensure products meet quality standards consistent with Customer Requirement, while meeting all design control and other regulatory requirements, including, but not limited to FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 11608 & ISO 14971. 【Main Responsibilities】 • Team member representing Quality on new product/process development and product care projects. • Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements. • Assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – UFMEA, DFMEA, PFMEA. • Develop quality plans and work further with Manufacturing on the transfer of quality requirements. • Promotes the use of statistics in the testing and control of quality. • Supports Device product/process development and production activities, including the following: - Develops or reviews product/process verifications/validation or test plans (protocols and reports). - Develops or reviews product/process specifications and requirements. - Develops or reviews product reliability specifications/predictions, reliability test activities. - Participates in risk management activities including review failure mode effects analysis (FMEA), hazard analysis, - fault tree analysis (FTA) and/or risk or statistical analysis. - Participates in product or process design and change activities, including design reviews. - Provides technical support for product quality attributes/decisions. - Support selected verification/validation activities (e.g., toxicology/biocompatibility, sterilization validation, etc.)with external suppliers. • Contributes to compilation and maintenance of Design History Files (DHF). • Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland, SHL has sites in Sweden, Taiwan, and the Unites States. 【Job Overview】 我們正在尋找撰寫風險管理檔案(RMF)的人員，你會頻繁的與客戶和內部設計及研發單位溝通合作，運用工程及法規的知識，以提供符合標準的RMF。 The role requires application of regulatory and engineering knowledge to deliver Risk Management Files (RMF) for the device designed and manufactured by SHL Medical. The candidate will work with customers and internal stakeholders such as Design and Regulatory Affairs (RA) team to outline SHL Medical’s risk management scope and deliver the RMF in compliance with but not limited to ISO 13485, ISO 14971, ISO 11608. 【Main Responsibilities】 • Participate in project intake activities to understand and assess feasibility of project proposals from risk management perspective. • Communicate and work together with customers and their representatives (clinical experts) to request and review Medical Harm List (MHL) that meets SHL requirements for intended device. • Initiate Risk Management Plan (RMP) and Hazard Identification Checklist (HIC) and align the overall risk management deliverables with internal stakeholders and customer. • Review D-FMEA and P-FMEA from design and risk assessment lead for content accuracy and the risk control measures applied for overall risk acceptance. • Attend relevant project meetings to ensure all information required to develop, update, and maintain risk management documents for related projects are captured and utilized effectively. • Participate in relevant product lifecycle management activities to provide/collect information and ensure RMF are updated periodically. Changes to RMF may be initiated by but not limited to change control, audits, design changes, regulatory requirements and customer request. • Participate in internal and external regulatory audits and inspections, including third party audits of product risk management and relevant design history files. • Ensure periodic review of post market data with supervisor and RA personnel to update device risk management file as needed. • Cascade any information from Risk Management File updates to risk assessment and project team to ensure concise communication and effective implementation of changes. • Where needed, participate and contribute on end-to-end device risk management process in SHL Risk Management improvement activities and gap remediations. • Escalate potential issues and changes that may impact device risk management files to related team members and participate in the recovery plans to ensure business risk and compliance risk are handled in timely manner. • Maintain periodic communication with customers to ensure engagement and information exchange between SHL and customer to maintain effectiveness and compliance of device RMFs. • Remain updated proactively with regulatory changes and compliance changes and escalate for discussion with Risk Manager to assess impact and changes required to risk management process and device RMFs. 【Skills and Qualification】 • Masters in Life Science Engineering discipline with 2 years of work experience (or) Degree with 5 years of work experience. Exposure to medical device, pharmaceutical or biotechnology industry is added advantage. • Trained on Quality System Regulation, Risk Management or Design Control courses. • Demonstrated and applied a broad knowledge in quality management assignments and risk management approaches. • Good communication and interpersonal skills and demonstrate ability to participate in inter-departmental projects and resolve quality-related issues in a timely and effective manner.

Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請： https://www.shl-medical.com/careers/jobs-at-shl-medical/qa-rca-engineer 【RCA Engineer】為了提升調查效率以及避免不斷重覆調查，Root cause analysis 根本原因分析工程師將負責制定及提供根本原因分析 (Root cause analysis, RCA) 調查流程，將此系統化後開設教育訓練輔導內部工程師，以達到我們的目標。 SHL Medical AG is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018. Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine. 【Job Overview】 This position is to provide quality oversight to assure design, development, manufacturing and post-market of SHL product are compliant to applicable regulations, standards, and SOPs. QA engineer ensures the delivery of high quality product which meet the regulatory requirements and customer expectations. 這個職位的目的是進行品質把關，確保 SHL 產品的設計、開發、製造和上市後階段皆符合相關法規、標準和標準作業程序 (SOPs)。品質保證工程師需確保產品的高品質交付，並滿足法規要求和客戶期望。 【Main Responsibilities】 ‧ Develop and deliver training programs on RCA methodologies, tools, and best practices. ‧ Conduct workshops, seminars, and hands-on training sessions to enhance the RCA skills of investigation Plan owners. ‧ Provide coaching and mentorship to individuals or teams to improve their RCA capabilities. ‧ Monitor the performance of RCA investigations across various projects or departments. ‧ Analyze investigation outcomes and identify areas for improvement. ‧ Implement KPIs to measure the effectiveness and efficiency of RCA processes. ‧ Continuously evaluate and refine RCA processes and methodologies to ensure effectiveness and efficiency. ‧ Collaborate with cross-functional teams to implement process improvements and standardize RCA practices across the organization. ‧ Stay updated on industry trends, emerging technologies, and best practices related to RCA. ‧ Foster a culture of collaboration and knowledge sharing among team members involved in RCA. ‧ Collaborate with various departments to gather relevant data and insights for RCA investigations. ‧ Communicate findings, recommendations, and action plans to stakeholders iin a clear and concise manner. ‧制定並提供有關 RCA 方法、工具和最佳實踐的培訓計劃。 ‧舉辦工作坊、研討會和實踐培訓課程，以提高調查計畫負責人的 RCA 技能。 ‧為個人或團隊提供輔導和指導，以提高他們的 RCA 能力。 ‧監控各個專案或部門的 RCA 調查績效。 ‧分析調查結果並確定需要改進的領域。 ‧實施KPI 來衡量 RCA 流程的有效性和效率。 ‧持續評估和完善 RCA 流程和方法，以確保有效性和效率。 ‧與跨職能團隊合作，實施流程改善並標準化整個組織的 RCA 實踐。 ‧隨時了解與 RCA 相關的行業趨勢、新興技術和最佳實踐。 ‧在參與 RCA 的團隊成員之間培養協作和知識共享的文化。 ‧與各部門合作，收集 RCA 調查的相關數據和見解。 ‧以清晰簡潔的方式向利害關係人傳達調查結果、建議和行動計劃。 【Required Skills & Qualifications】 ‧ BS degree above or equivalent technical work experience. ‧ Clear / logical thinking with strong organization and communication skills ‧ Proficient problem solving skills. ‧ Working knowledge of Microsoft Office. ‧ Experience in the medical device industry is preferred. ‧ Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred. ‧ CQT (certified quality technician), CQE (certified quality engineer) is a plus. ‧ Six sigma green belt or black belt is a plus. ‧ 工程學士學位以上或品質/製成相關工作經驗。 ‧ 具有清晰/邏輯思維和良好的組織和溝通能力。 ‧ 熟練的解決問題能力。 ‧ 熟悉Microsoft Office軟體。 ‧ 具有醫療器械行業經驗者優先考慮。 ‧ 熟悉法規合規要求：GMP、QSR、和ISO 13485者優先考慮。 ‧ 持有CQT（認證品質技術員）、CQE（認證品質工程師）證書者優先加分。 ‧ 擁有六標準差綠帶或黑帶證書者優先加分。