1. 產品檢驗工作。 2. 品質異常分析與改善追蹤。 3.執行設備內/外校驗。 4. ERP系統操作與維持。 5. 品質系統文件維持。電機工程學類,工業管理學類,機械工程學類

1.檢查、測試、或測量材料、產品、裝置，使之符合規格。 2.使用測量儀器測量產品的尺寸以符合規格。 3.了解相關ISO流程和文件資料填寫及標示。 4.不良品或客訴對外處理及報告分析、回覆 5.其他主管交待事項。輕型機車,普通小型車,普通重機車

1. 製作與修訂各產品檢驗作業指導書。 2. 製作出貨品質文件（測試報告及 C of C）。 3. 量測工具、設備校驗規劃與執行。 4. 執行各產品的檢驗工作及檢驗技術的持續改善。 5. ERP 帳務處理。電機工程學類,工業管理學類,機械工程學類

還在猶豫要往品保或品管領域深耕嗎？ 那你(妳)的機會來囉! 此職缺能讓你(妳)歷練到這兩個領域，增加職涯的廣度。 快來按下我要應徵，並在自我推薦信寫下你(妳)的與眾不同。 期待您的加入! 【你(妳)需要做的事】 ◆ 執行與推動 QMS 品質系統 ◆ IQC/IPQC/OQC/環境監測等試驗分析 ◆ 撰寫及執行品質系統相關之確效與驗證 ◆ 協助內部稽核與外部認證之相關工作 ◆ 其他公司交辦事項 【加分條件】 ◆ 品管相關經驗1年以上 ◆ 具藥廠相關文件撰寫及執行經驗優先 ◆ 具生技產業之品保、製造、分析經驗者優先。 【你(妳)需具有的能力/特質】 ◆ 溝通協調與表達能力良好 【工作型態與待遇】 ◆ 本職務需輪班(早/中/夜班)，輪班津貼另計。 ◆ 本職缺顯示之待遇為早班月薪，將視學經歷核薪。食品科學類,藥學學類,化學學類

1.檢查、測試、或測量材料、產品、裝置，使之符合規格。 2.使用測量儀器（如：尺規或測微器等）測量產品的尺寸以符合規格。 3.主管交待事項。輕型機車,普通小型車,普通重機車

1.依公司流程執行品保工作、並作品質改善 2.製造過程中之製程巡檢、實施品管計畫 3.原物料、半成品，成品、包裝、出廠之品質檢驗以及判定 4.製程管制，掌握品質變異狀況，解決問題，負責產品品質水準之穩定 5.不合格品原因之追查、分析、報告以及處理 6.需配合加班普通小型車,普通重機車

1.醫療器材上市後監督管理活動 2.品質資料分析、改善與追踨管理 3.協助品質管理系統推動與維護 4.協助各國醫療器材相關法規搜集與維護。 5.其他主管交辦事負商業及管理學門

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 since late 2018, with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Factory Development & Projects team within our Global Operations Engineering group in Taiwan. You are · Student in Engineering, Applied Sciences or other equivalent education · Independent thinker who is willing to discover new solutions off the beaten tracks · Interest in advanced high-volume production technologies, process automation / robotics, control engineering, equipment design and medical manufacturing · Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Process Automation, Digital Manufacturing/I4.0, Factory planning, Logistics, Plant simulation · Strong intercultural and interdisciplinary communication skills in English (spoken/written) · Diligent, reliable and target oriented team player · Knowledge of JavaScript, Python or VBA is a plus We offer · A variety of challenging internship opportunities across multiple products and disciplines within our Global Operations Engineering Team · The opportunity to solve real-world problems in a growing, future-proof industry · Competitive compensation, Labor and group insurance · Local HR support (Relocation and Accommodation as applicable) · Dedicated on-site senior mentor guidance · Asia-experience in a highly innovative, international company · Flexible work-from-home policy · Start date: flexible upon agreement機械工程學類,資訊工程學類,工業工程學類

QE team expand in 2023! We‘re lookng for the experienced partner working together! Job Overview The Quality Engineer 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 Required Skills & Qualifications • Education:Technical / scientific degree at college / university level (mechanical, industrial, biomedical, chemical engineering, material/life science) Experience_Occupational experience • At least five years’ work experience in a Product Development/Design Assurance function in regulated environment (medical devices/Diagnostic instrumentation industry, pharmaceutical or biotechnology industry.) • Experience in the design and development of products in accordance with ISO 13485 guidelines. • In depth know-how and experience of quality techniques: Six Sigma Blackbelt, Six Sigma methods such as DFSS, DMAIC, DoE, FMEA, etc. • Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testings • Experience in the entire Design life-cycle and Phase-Gate development process. Experience_Special knowledge, expertise, experience • cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC • Statistical methods • SAP (Manufacturing Execution Systems / MES will be an advantage) • English (spoken and written), local language (Mandarin) is a plus自然科學學門,工程學門

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 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機械工程學類,材料工程學類,工業工程學類

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 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機械工程學類,工業工程學類,化學工程學類

【Job Overview】 This position is a senior technical role in the Molding Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Lead and develop a team of experts to support the production of injection molded components for our autoinjector systems ● Understand current practices and develop new or improved scientific molding processes and methodologies based on in-depth processing experience, plastics engineering fundamentals and materials science knowledge. Promote use of new technologies and industry-leading trends. Provide highest level of technical expertise ● Lead engineering accountability for molds, component manufacturing and corresponding processes within our production system ● Collaborate closely with Plant / Production manager, 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 improvement programs and capacity deployment in injection molding ● Accountable for manufacturing acceptance of new molds in regular production ● Lead Design For Manufacturing (DFM) and definition of manufacturing requirements for new products and product care initiatives ● Organize and lead plant level training activities to improve molding problem solving capabilities and process efficiencies 【Your qualification】 ● Degree in Mechanical Engineering, Polymer Science or similar education/experience ● Minimum 15 years of relevant industry experience with hands-on experience with multi-cavity hot runner injection molding systems ● Deep understanding of mold and machine setup, molding machine operation, process optimization, as well as mold design/function. ● Thorough understanding and excellent hands-on experience with auxiliary equipment (i.e. Hot runners, controllers, Polymer dryers, Thermolator, Mold heaters, robot/take out systems, etc.). ● Advanced knowledge of engineering resin characteristics / validation of new polymer materials and molding processes for medical grade polymers. ● Statistical analysis knowledge, including an understanding of Scientific molding processes, the mold- machine- material- process interactions, Design of Experiments (DoE) and mold qualification protocols ● Advanced knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies ● Proven track record in leading and developing a team of highly specialized experts; management experience ● Advanced knowledge in process development, verification and validation ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● 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) ● Ability to communicate in Mandarin is highly desirable 【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化學工程學類,機械工程學類,工業工程學類

【About Us】 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. The strong competition around the globe, comes from the Intelligence property we owned in Europe and USA, the vertical integration from the tool design, to state of art industrial 4.0 footprint throughout the processes and great QMS/RA intelligence to ensure we deliver the most reliable products. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine. 【Main Responsibilities】 ● Develop the test procedures for the medical device reliability testing, design assessment/verification, and certification testing, meanwhile following it to perform the testing. This may include but is not limited to environmental, mechanical safety, electronic, and certification testing. ● Perform product reliability prediction(MTTF/MTBF), shelf-life test(real time, accelerated aging), environmental test, failure analysis(8D, FMEA, FTA, Fishbone). ● Follow the regulations (e.g IEC 60601, IEEE, ISO) to conduct the test activities for product function, safety, and EMI/EMC certification/verification activities ● Follow strictly to established prepare technical reviews, technical reports, and verification/validation test reports ● Set up and run test equipment in accordance with the standard operating procedure (SOP) or working instruction (WI) ● Multi-tasking, manage the testings at the same time and providing timely updates on testing progress at agreed intervals ● Conduct root cause analysis reviews by 8D, Fault Tree Analysis(FTA), 5-WHY and fishbone with teams to facilitate a corrective action program and resolve technical and reliability issues ● Carry out other duties as assigned. 【Required Skills & Qualifications】 ● Bachelor’s degree in mechanical or electrical engineering ● 4-6 years related working experience with quality and reliability testing including mechanical stress tests, shock/drop/vibration testing, environmental testing and electronic device testing in EMC/EMI, Product Safety accreditation ● Familiar with IEC60601 regulations ● Advanced verbal and written communication skills (TOEIC 700+) ● Able to work independently ● Excellent analytical and troubleshooting skills機械工程學類,電機工程學類,電子工程學類可靠度工程師(CRE)

【Job Overview】 This role is embedded in the Factory Development & Projects Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Lead the development and implementation of factory and plant layouts together with our internal planning and SME teams and external contractors (architecture, design, planning, etc.) ● Ensure all stakeholder requirements are considered in the planning process and are translated into optimized factory designs, both from an Operational and Sustainability standpoint ● Review factory design and optimize site layouts for production, material flow, construction, and facilities. ● Convert identified potentials in production and logistics processes into a competent planning. ● Ensure compliance with relevant Codes, Standards and HSE requirements ● Ensure execution of standards, processes and procedures for effective delivery of operations excellence ● Work with manufacturing, logistics, facilities teams and contractors to ensure that equipment and layout designs align with the overall logistics and operational plans of for the factory ● Factory equipment and facilities: 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. ● Support integration of systems and processes in to global digital landscape (EWM, EAM, MES,…) ● Provide technical leadership support to Project Managers to drive planning, implementation and project execution with the team ● Review and approval of critical layouts and facility specifications (space allocation, material flow, MEP, etc.) 【Your qualification】 ● Degree in Engineering, Construction, Production Management or other relevant discipline ● Minimum 10 years of relevant industry experience in Production Management, Operations/Logistics or Factory Planning/Design ● Hands-on production/logistics management experience in a high-volume, high-throughput production environment; Familiar with LEAN process optimization ● Proficient in layout design (preferably AutoCAD) and relevant drawing standards ● Knowledge of automated material handling / warehouse systems, production logistics, end of line installations, warehouse transportation and material flow optimization ● Knowledge of MEP and logistics requirements for large scale, high-volume production facilities ● Experience with ASRS (Automated Storage and Retrieval Systems) warehouse systems, AGV, conveyance, logistics, distribution, RFID and Material Flow Methods is highly desirable ● Experience with system integration to electronic warehouse and asset management systems(EWM/EAM) is highly desirable (preferably SAP) ● Experience designing greenfield facility layouts ● Project Management experience ● 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 ● Ability to assess and solve complex issues and tackle problems with limited initial information. ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) ● Ability to communicate efficiently in Mandarin 【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機械工程學類,工業工程學類,化學工程學類

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 since late 2018, with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Packaging and Forming Technology team within our Global Operations Engineering group in Taiwan. You are · Student in Engineering, Applied Sciences or other equivalent education · Independent thinker who is willing to discover new solutions off the beaten tracks · Interest in advanced high-volume production technologies, process improvement and medical manufacturing · Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Packaging or Polymer Technology, Industrial printing processes (Pad, Screen, Laser), Packaging design · Strong intercultural and interdisciplinary communication skills in English (spoken/written) · Diligent, reliable and target oriented team player We offer · A variety of challenging internship opportunities across multiple products and disciplines within our Global Operations Engineering Team · The opportunity to solve real-world problems in a growing, future-proof industry · Competitive compensation, Labor and group insurance · Local HR support (Relocation and Accommodation as applicable) · Dedicated on-site senior mentor guidance · Asia-experience in a highly innovative, international company · Flexible work-from-home policy · Start date: flexible upon agreement機械工程學類,資訊工程學類,工業工程學類

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 since late 2018, with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Factory Development & Projects team within our Global Operations Engineering group in Taiwan. You are · Student in Engineering, Applied Sciences, Business Administration or Management · Independent thinker who is willing to discover new solutions off the beaten tracks · Previous experience / training in Project and/or Operations Management · Knowledge of common collaboration and productivity tools in MS O365 · Interest in Project Analytics, Continuous Improvement, Operations Management · Strong intercultural and interdisciplinary communication skills in English (spoken/written) · Diligent, reliable and target oriented team player · Knowledge of JavaScript, Python or VBA is a plus We offer · A variety of challenging internship opportunities across multiple products and disciplines within our Global Operations Engineering Team · The opportunity to solve real-world problems in a growing, future-proof industry · Competitive compensation, Labor and group insurance · Local HR support (Relocation and Accommodation as applicable) · Dedicated on-site senior mentor guidance · Asia-experience in a highly innovative, international company · Flexible work-from-home policy · Start date: flexible upon agreement機械工程學類,資訊工程學類,工業工程學類

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 since late 2018, with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Automation Technology team within our Global Operations Engineering group in Taiwan. You are · Student in Engineering, Applied Sciences or other equivalent education · Independent thinker who is willing to discover new solutions off the beaten tracks · Interest in advanced high-volume production technologies, process automation / robotics, control engineering, equipment design and medical manufacturing · Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Process Automation, Digital Manufacturing/I4.0, Control Engineering, Equipment design, Robotics · Strong intercultural and interdisciplinary communication skills in English (spoken/written) · Diligent, reliable and target oriented team player We offer · A variety of challenging internship opportunities across multiple products and disciplines within our Global Operations Engineering Team · The opportunity to solve real-world problems in a growing, future-proof industry · Competitive compensation, Labor and group insurance · Local HR support (Relocation and Accommodation as applicable) · Dedicated on-site senior mentor guidance · Asia-experience in a highly innovative, international company · Flexible work-from-home policy · Start date: flexible upon agreement機械工程學類,資訊工程學類,工業工程學類

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 since late 2018, with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Molding Technology team within our Global Operations Engineering group in Taiwan. You are · Student in Engineering, Applied Sciences or other equivalent education · Independent thinker who is willing to discover new solutions off the beaten tracks · Interest in advanced high-volume production technologies, process improvement and medical manufacturing · Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Polymer Science, Plastics Engineering, Injection Molding / Tooling Technology, Product Development, Process Development · Strong intercultural and interdisciplinary communication skills in English (spoken/written) · Diligent, reliable and target oriented team player We offer · A variety of challenging internship opportunities across multiple products and disciplines within our Global Operations Engineering Team · The opportunity to solve real-world problems in a growing, future-proof industry · Competitive compensation, Labor and group insurance · Local HR support (Relocation and Accommodation as applicable) · Dedicated on-site senior mentor guidance · Asia-experience in a highly innovative, international company · Flexible work-from-home policy · Start date: flexible upon agreement機械工程學類,資訊工程學類,工業工程學類

1. 醫療器材QSD申請 2. QMS/GDP品質系統文件撰寫 3. 內部稽核 4. QMS教育訓練 5. 英文閱讀流利工程學門,醫藥衛生學門普通小型車普通小型車

這個職位需要具備深入了解當地和國際醫療器材相關法規條款的知識，並確保公司的醫療器材產品符合所有的法律和法規要求。該職位需要與內部團隊合作，包括研發、品質管理、製造以及行銷部門，以確保所有醫療器材的設計、生產和行銷過程符合相關法規和法律標準。 主要任務: 1. 負責國內外醫療器材認證及查驗登記。 2. 醫材產品與系統證書管理 3. 醫材追溯系統登錄與管理 4. 負責公司醫療器材產品取得功能性、安全性及符合相關法規之檢驗報告。 5. 商標與專利、產品責任險申請、註冊、維護 6. 確認產品（醫療器材）中英文標示、廣告宣稱內容是否符合法規。 7. 國內外醫療器材相關法規、標準、證照申請資料之蒐集/彙整更新及維護 8. 協助產品開發過程中，相關法規諮詢 (FDA/EU/ISO/MDR)。 9. 基本醫療器材法規、品質工程及熟悉ISO 13485、相關醫療器材稽核應對經驗及稽核後CAPA的回覆 10. 協助業務處理客戶有關產品品質、認證或工廠資訊等相關資料的統整、確認。 11 執行主管交辦事項。