7,766 Results
﹝台灣北部地區, Cardiac Rhythm Management ﹞Clinical Specialist Medtronic (Taiwan) Ltd._美敦力醫療產品股份有限公司
Salary negotiable
台北市松山區
經歷不拘
* Work within and actively promote Medtronic’s core mission, corporate strategies, policies, procedures and Code of Conduct. * Represent Medtronic during surgeries, implants and follow-ups in hospitals. * Demonstrate expertise and provide consultancy services in all aspects of implant and troubleshooting techniques if required. * Provide on call support as needed for surgeries, reprogramming, troubleshooting, follow-up, etc. on evenings and weekends. * Fully master knowledge regarding pacing, Medtronic programs, products and services and competitive products. * Provide support with technical investigations and clinical trials collection in assigned institutions. Ensures completion of necessary documentation. * Complete service report timely. * Monitor technical performance of dealer to ensure required quality. * Educate and train technicians of hospital and dealer on matters.
Full-time
Entry-level
English Required
9/16 Updated
﹝台灣北部地區, Ear, Nose and Throat﹞ Territory Representative/Specialist/ Supervisor Medtronic (Taiwan) Ltd._美敦力醫療產品股份有限公司
Salary negotiable
台北市松山區
1年以上
* Comply with Medtronic’s Business Code of Conduct. * Gain fundamental knowledge of disease management and able to convince customer with product features and benefits with scientific evidence (detailing aids). * Provide technical backup at follow-ups, clinics and implants as required if applicable. * Define customer list and set priority, then conduct sales calls with proper timing to promote assigned products and provide services to existing customers. * Know advocacy within responsible accounts to assure access and product availability. * Know customer’s practice and needs to further provide solution with MDT products and timely services. * Start business conversation with customers, then provide basic knowledge of cross team to them to enhance overall MDT business potential. * Learn to collect and report market intelligence of account/territory sales achievement, concerning overall MDT business. * Assist in most sales and marketing activities to maximize Medtronic revenue within assigned territory. * Learn to adopt corporate systems effectively in daily sales operation to optimize sales activities in line with accounts and sales plans and also to monitor inventories and maintain accurate consignment.
Full-time
Mid to Senior Level
English Required
9/16 Updated
HR Specialist Zimmer Biomet_台灣捷邁醫療器材股份有限公司
Salary negotiable
台北市松山區
經歷不拘
Summary: Responsible for managing day-to-day HR operations across the full HR spectrum, with a focus on employee service delivery and recruitment, as well as handling ad-hoc projects and other duties as assigned. Duties & Responsibilities: Employee Service Delivery • Initiate and coordinate well-being programs and engagement activities. • Lead employer branding initiatives, including organizing sports days, DEI events and external selection, etc. • Act as HR contact window to provide services such as policy explanations and address employee queries and concerns. • Manage vendor contracts and oversee purchase order applications to ensure timely and accurate processing. • Serve as the HR system administrator, maintaining accurate records and providing timely support to HR processes. Recruitment • Oversee the complete recruitment lifecycle, including candidate sourcing, screening, selection, hiring, onboarding, probation review, and offboarding processes using the SuccessFactors. • Prepare consolidated reports and conduct analysis of recruitment metrics to identify areas for process and recruitment improvements. • Assist in developing and designing recruitment strategies, which include consolidating job descriptions, implementing innovative sourcing techniques to attract top talent, and managing internship programs, etc. Payroll • Support payroll preparation process as consolidate the insurance enrollment tickets, monthly OT report and leave report. Others • Support various ad-hoc activities and assignments as required to meet organizational needs. • As the HR systems owner to ensure timely and accurate management such as Success Factors, local websites and leave system, etc.
Full-time
Entry-level
English Required
8/30 Updated
International Sales Manager 艾克夏醫療儀器股份有限公司
Monthly Salary NT$ 80,000+
台南市新市區
5年以上
International Market Development: *Conduct in-depth research on target international markets, focusing on excimer laser and femtosecond laser surgery trends. *Expand into foreign markets, and develop new sales channels and clients, particularly ophthalmic medical institutions. *Participate in international ophthalmology exhibitions and conferences to expand business networks. Sales Management: *Maintain good relationships with international clients, distributors, and partners. *Negotiate and sign sales contracts, ensuring alignment with company interests. *Manage sales orders and shipments, ensuring timely delivery and providing support. *Handle customer complaints and after-sales issues. Sales Target Achievement: *Set individual and team sales targets. *Monitor sales performance and provide improvement suggestions. *Motivate and guide the sales team. Product Promotion: *Familiarize oneself with the company's ophthalmic surgical systems and their clinical applications. *Provide training, technical support, and clinical guidance to international clients. *Assist the marketing department in implementing product promotion strategies. Competitive Intelligence: *Closely monitor competitor activities. *Gather and analyze competitive intelligence. Clinical Support: *Provide clinical guidance to international clients during surgeries. *Collaborate with clients' medical teams, addressing questions and offering technical advice.
Full-time
Manager/Director
English Required
9/19 Updated
QE - Quality Engineer (Process - Molding&Tooling) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
2年以上
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!目前部門擴大招募中,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
Full-time
Mid to Senior Level
English Required
9/12 Updated
QE - Quality Engineer (Process - Automation&Assembly) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
2年以上
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!目前部門擴大招募中,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
Full-time
Mid to Senior Level
English Required
9/12 Updated
【QA】品保工程師/資深工程師Quality Assurance Engineer/Senior Engineer(台北/新竹) Altek Biotechnology_榮晶生物科技股份有限公司
Salary negotiable
台北市內湖區
3年以上
hazardous substances information for components and products approval. 負責有害物質管理系統,包括定期更新醫療器材適用之法規標準,具備針對新制定或更新之法規與標準之風險分析與影響評估,蒐
Full-time
Senior Level
English Required
9/18 Updated
QE - Senior Quality Engineer (Process - Automation&Assembly) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
5年以上
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!目前部門擴大招募中,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 Senior
Full-time
Manager/Director
English Required
9/12 Updated
PDMP - Senior Metrology Engineer(Application Engineer/Project Owner) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
3年以上
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
Full-time
Senior Level
9/16 Updated
Testing - Design Verification Engineer 設計驗證工程師 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
經歷不拘
【Job Overview】 SHL Medical is looking for a talented Design Verification Engineer to develop the next generation of medical devices. This role offers a chance to make a difference in a company focused on engineering, working on products ranging from single-use auto-injectors to advanced drug delivery solutions. Our global team is dedicated to advancing medical technology and improving how patients receive their medications. At SHL Medical, our employees are passionate about medical and mechanical engineering. We strive to enable patient independence by allowing them to receive medications without needing to visit hospitals or clinics. 【What you’ll be doing...】 • Verify the design, materials, and components of medical devices for various product generations at both component and system levels. • Develop and integrate test plans and methods across different verification environments. • Create and validate test methods, including developing fixtures and writing validation reports. • Conduct studies on drug delivery systems to support worst-case test scenarios. • Help develop and test design prototypes. 【What we need to see...】 • Bachelor’s degree in engineering or a related science field. • Experience in designing fixtures and analyzing mechanical test setups. • Strong knowledge of mechanical validation testing and data collection. • Ability to automate mechanical tests. • Understanding of material failure analysis or data analysis. • Skills in statistical analysis. • Familiarity with industrial manufacturing processes. • Knowledge of Good Laboratory Practice (GLP) and Good Documentation Practices (GDP). 【Ways to stand out...】 • Hands-on experience in designing and testing mechanical products. • Proficiency in using mechanical engineering tools for test method development. • Strong problem-solving and analytical skills. • Excellent written and verbal communication in English. • Good interpersonal skills and a team-oriented mindset. With competitive salaries and great benefits, SHL Medical is considered one of the best employers in the world. We have some of the brightest and most talented people working with us. If you are creative, independent, and enjoy challenges, we want to hear from you. We are an equal opportunity employer and value diversity in our company. *** We welcome fresh graduates and will provide comprehensive training sessions. ***
Full-time
Entry-level
English Required
9/12 Updated
Core Diagnostics - Technical Application Specialist (台南高雄) 美商亞培股份有限公司台灣分公司
Salary negotiable
高雄市苓雅區
2年以上
Main Responsibilities:* The position serves as the primary contact for clarifying reagent report interpretation and troubleshooting; providing reagent correlation and application; as well as technical education for customers before and after instrument installation. It also provides support to the sales and service team for business growth. The main job responsibility will be: - Deliver Customer Operator training in Abbott facilities or on-site - Perform new instrument and assay implementations through to Test of Record - On-site assay investigation, troubleshooting and operator training and coaching
Full-time
Mid to Senior Level
English Required
9/20 Updated
SHINMED-International Sales Rep. [Medical Device]醫材國外業務 升望科技股份有限公司
Monthly Salary NT$ 45,000+
新北市五股區
3年以上
With over 33 years of medical device manufacturing, we're seeking passionate individuals to bolster our international sales team. 1. Develop and Manage Relationships: Seek new business opportunities, including CDMO, ODM, OEM, and our brand-SHINMED, and nurture existing client relationships. The target markets are North America and Europe. 2. Attend Exhibitions and Visits: Showcase products and services globally to expand market presence. English is a must, other languages(German, Spanish, French...) will be a plus. 內部溝通以中文為主,需有中文溝通能力。
Full-time
Senior Level
English Required
9/19 Updated
AMSD - Project Engineer 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
經歷不拘
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. Responsibilities : 1.Allocate resources required to execute a project. 2.Create the official project schedule. Review schedule with customer and project team. 3.Organize all the project activities and follow-up. 4.Organize project kick-off, design review, and project status update meetings. 5.Follow up on action items of kick-off, design, and project status update review meeting. 6.Provide project status reports to management weekly or under request. 7.Monitor and ensure engineering design and documentation are on time and complete. 8.Root cause analyzing and problem-solving for project issue 9.Support FAT with the customer. 10.Support actions to customer service requests and complaints. 11.Execute approved customer changes, update the official schedule as needed. 12.Proactively identify and manage the risks of the project.
Full-time
Entry-level
English Required
7/22 Updated
OE - Manufacturing Project Engineer (Molding Technology) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
2年以上
【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. This role is embedded in the Molding Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 1. Together with the rest of your team you will support the production of injection molded components for our autoinjector systems 2. Collaborate closely with shopfloor production technicians, tool makers and maintenance, quality and process development on performance/process improvements and trouble shooting 3. Lead the development of improvement plans and requirements for capacity expansion and future mold generations and production setups 4. Lead cross-functional Root Cause Analysis and Event Response Investigations 5. Lead cross-functional improvement projects and capacity deployment projects 6. Coordinate manufacturing acceptance of new molds and process in regular production 7. Coordinate Design For Manufacturing (DFM) assessments and definition of manufacturing requirements for new products
Full-time
Mid to Senior Level
English Required
9/16 Updated
Comm - Senior Specialist 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
5年以上
【Job Overview】 As a Senior Specialist in Regional Communications, you are responsible for internal and external communications, public relations, and internal/external events at SHL within your specified region. You will be building and maintaining trusted relationships with local media representatives, and community leaders on behalf of the company. You will create and nurture a positive public image and reputation of SHL and represent our interests through interacting with key stakeholders. You are responsible for developing and implementing effective internal communication assets for your location that are both clear and engaging. Furthermore, you will support the local managing director by participating in events. You will plan and organize SHL-owned and SHL-participated external commercial events and will contribute to creating an overview of all local events for alignment with global events. 【Main Responsibilities】 Media and Public Relations: Manage local media relations by monitoring and proactively reaching out to regional media. Proactively shape the media and public relations strategy for your region. Coordinate media requests and external communication, e.g. for the website, or press releases on a regional level. Shape and nurture a positive public image, enhance reputation, and foster mutually beneficial relationships by engaging with various stakeholders. Executive Management Communication:Develop communications for SHL’s TW senior management, including writing announcements, designing speeches, and preparing presentation material. Coordinate internal communications events such as town hall meetings by deciding on speakers, defining the topics, selecting the venue, etc. e internal communications events such as town hall meetings by deciding on speakers, defining the topics, selecting the venue, etc. Internal Communication: Producing internal communication, such as creating and uploading TW announcements for our e.g. our Intranet and digital signage displays. You will act as a sparring partner for the TW senior management and play a decisive role in management, change, and crisis communication. Change Communication: Create communication plans for change initiatives and collaborate with change initiative teams to define how to convey a message in the most effective way. Support and challenge change initiative teams in refining their communication content. Crisis Communication: Further develop our crisis communication manual and drives in regular crisis simulation events. Collaborate with PR and external communication team to align internal and external crisis approach. Event Participation Support: Support the managing director in TW in participating in local events (e.g., trade fairs and exhibitions, conferences and congresses, technology and innovation summits). Prepare and brief the managing director, decide on topics to address and create speeches, evaluate participant list and identify key stakeholders, etc. Ensure effective presentation of SHL, which contributes to building brand awareness and company reputation. Event Organization: Secure efficient execution of regional event participation and regional event hosting. In coordination with the global events team, manage activities pre, during, and post events, leading preparation, guiding execution, and conducting after-event analysis (e.g., reporting on media outreach). Support the global events team to develop and implement standardization of processes, governance, tools, and systems across events to improve effectiveness and resource efficiency of all stakeholders involved. Cross-country / Cross-Functional Collaboration: Proactively and regularly align with SHL responsibilities for global events. Contribute to creating an overview of local events to make sure these are aligned with global events. Collaborate with other commercial teams to create a coherent and positive external appearance of SHL.
Full-time
Manager/Director
Partially Remote
8/28 Updated
Comm - Senior Webmaster (網站開發管理) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
3年以上
Job Overview As a Senior Webmaster, you will be responsible for developing, optimizing, and maintaining our website and supporting our internal communications channels such as intranet, and digital signage displays. You will ensure that web strategies are aligned with our overall business goals, make sure that content is relevant, engaging, and up to date, and secure a seamless and engaging user experience. By implementing SEO best practices and analyzing website performance metrics, you will drive continuous improvement and organic traffic growth. Your expertise will help us stay ahead of industry trends and maintain a competitive edge. As Senior Webmaster for SHL, you are a self-starter who proactively works to improve the website and come up with suggestions on your own. You need to be comfortable with stakeholder management, such as presenting progress and improvement to senior management. You will also supervise an internal communication channel specialist who will be working on the internal communication channels, such as intranet, and digital signage displays. Main Responsibilities 。Website Development and Management: Develop, maintain, and continuously improve SHL Medical’s and its subsidiaries' websites. This includes working with web developers, designers, and content creators to ensure the website is up-to-date, visually appealing, user-friendly, and aligned with the company's branding and messaging. You would need to be highly proficient in CMSs like WordPress or preferably Umbraco. You also need to know how to develop less complex components etc. for the website, this means you need to have a good understanding of JavaScript, CSS, and HTML. 。Content and Lead Generation: Collaborate with marketing and communication teams to develop and execute content strategies and lead generation tactics for the website. Ensure that the content is relevant, engaging, optimized for conversion and lead generation and targeted to SHL Medical’s various audiences. 。Search Engine Optimization(SEO): Develop the SEO strategy and implement SEO best practices to improve the website's visibility in search engine results and drive organic traffic to the site. Manage and promote interfaces with various external websites. Manage SEO audits, keyword research, and on-page/off-page optimization efforts and oversee continuous implementation of the SEO strategy. 。Web Technologies Integration: Collaborate with IT and software development teams to integrate web technologies, such as chatbots, interactive tools, customer platforms, and customer support features, into the website. 。Develop landing pages for Marketing campaigns that convert visitors into prospects. Integrate social media platforms into the website and leverage social media for website promotion and engagement. 。Analytics and Reporting: Monitor website performance using analytics tools, analyzing user behavior, and generating regular reports to track key metrics and identify trends. Use generated insights to make data-driven decisions to improve the website's effectiveness. 。Cross-Functional collaboration: Work closely with marketing, sales, product development, and other teams to align web and front-end strategies with overall business goals. Facilitate communication and coordination among various stakeholders to support web initiatives. 。Internal communication channel Development and Management: Oversee the internal comms channels, such as SharePoint intranet, and Digital signage displays. 。Trend Scouting: Stay updated with the latest trends, technologies, and best practices in web development, front-end design, SEO, and digital marketing. 。Identify opportunities for innovation and continuous improvement to maintain a competitive advantage.
Full-time
Senior Level
English Required
Partially Remote
8/27 Updated
DET QARA - [6 month Internship] Software Quality Assurance 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
經歷不拘
In this role, We are looking for a dynamic, energetic intern who is eager to learn about what you can achieve in SHL. You will be working closely with our team to conduct software testing, attend meetings where you will be asked to participate in the design of new challenging projects and support on the efforts to keep quality to its best. To be successful as an Intern, you should be willing to help with any tasks assigned by a supervisor. You will be involved in upcoming projects as well as assisting with current tasks. You are responsible for Test firmware that employs a variety of testing methodologies such as integration, regression, performance test, etc. Prepare test plans, test cases, and execute test cases Participate peer-review test cases Create detailed bug and test reports Involve Software Development Life Cycle (SDLC) both SiMD and SaMD To succeed in this role, you should have the following skills and experience Capable of preparing test plans, test cases and execution Good knowledge of C++/C and/or Python. Experienced to operating systems such as Windows and/or MacOS, Android and/or iOS General knowledge in software security risk assessment, a plus Fluent in English or fluent Mandarin with basic English. Able to work as a team What’s on offer? An exciting opportunity in a fast-growing international medical device company A modern working environment, with multicultural and dynamic teams Learning and development. Required documents CV | Cover Letter University Transcript (all required documents in English) Engineering background preferred
Part-time
Entry-level
English Required
8/27 Updated
DET QARA - (Sr.) Software QA Engineer (Automation Test) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
3年以上
*** DET(Development Emerging Technologies) QARA team is expanding in 2024! We would like to find a junior engineer and a senior engineer. *** 【About Us】 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 United States. 【In this role, you can】 Ensure full compliance, and solid product & process quality on design assurance of digital platform, software as medical device, health informatics and software component. 【Main Responsibilities】 • Design, implement, and document automatic or manual software verification plans to ensure product or in-house software quality meets the requirement specifications and medical software regulations, • Create, maintain, validate related tools used in hardware/software verification activities, • Identify software quality risks & process gaps and drive mitigation, • Provide guidance to project team members on SDLC processes & template requirements, and review software design deliverables, • Study related medical device standards/guidance and drive department improvement 【Required Skills & Qualifications】 • Bachelor's degree or higher in Computer Science or Engineering  • 2+ years in a Software/firmware Development Quality Engineering role • Fluent in python and with libraries of unittest, RestfulAPI, selenium, pyautogui • Experienced in building up automated software system, end-2-end, database testing (SQLite, MongoDB, MySQL, etc.) • Experienced in code version control tool (e.g. Git), and in project management tool (e.g. JIRA, Azure) • Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (IEC62304, ISO14971, UL2900, GAMP-5) is preferred • Result oriented, Team player, pragmatic & pro-active • English speaking/reading/writing
Full-time
Senior Level
English Required
8/27 Updated
RM - Risk Management Engineer 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
2年以上
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.
Full-time
Mid to Senior Level
English Required
9/12 Updated
DET QARA - Senior Supplier Quality Engineer(Electronic products) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
5年以上
*** DET(Development Emerging Technologies) QARA team will expand in 2024! Welcome all the potential candidates join us. *** 【About Us】 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 United States. 【Job Overview】 The Supplier Quality Engineer is responsible (a) To drive supplier quality performance, including new product development and product quality improvement (b) Overseeing supplier quality team and establishing quality control objectives (c) Ensuring the supplier regulatory and company requirements (d) Performing quality system audits and development good partnership with suppliers 【Main Responsibilities】 • Direct supplier qualification in accordance with outsourced material and part qualification system requirements specifications • Benchmark existing manufacturing supplier management procedure to establish and maintain supplier management activities for design and development teams • Work hand-in-hand with quality engineering team to establish critical-to-quality, acceptance criteria and testing requirements to outsourced suppliers • Develop Supplier Quality Agreement • Categorize the new supplier according to the procedure • Perform periodic supplier evaluation • Assist in sourcing, and assessing suppliers to supply the necessary material • Support the evaluation of supplier’s performance and supplier’s continuous improvement program • Visit supplier’s facilities and observe the manufacturing environment to review and assess their procedures. • Co-ordinate incoming tests and assessment on outsourced material and purchased component to verify quality requirements are met • Maintaining detailed reports on supplier quality, including defect rates and area for improvements • Providing technical advice and guidance to suppliers to reduce defect rates • Responsible for supplier audit including preparation, coordinating and assist in internal/external audits. Specialty: - Development of audit plan, audit schedules, audit report and follow-up audit findings - Perform data analysis for supplier audit performance - Keep abreast of industry standards and regulations • Review and approves supplier failure analysis relative to corrective action provided and coordinate resolution of quality assurance related problems. • Assign above job tasks by staffing qualification / personal ability / organization needs. • Carry out other duties as assigned. 【Required Skills & Qualifications】 • Bachelor’s Degree in engineering, science, or logistics, medical technology or other related science is required • Minimum 2 years’ experience in supplier management processes and engineering principles. • Familiar with ISO 9001 or ISO 13485 and ISO 14971 is preferred • Good working knowledge of quality control standards and government compliance. • Ability to analyze data and apply statistical techniques in order to improve process efficiency • Able to work well in a team and manage your own job load independently • Good interpersonal, written and verbal communication skills in English and Mandarin
Full-time
Manager/Director
English Required
8/27 Updated