DNV_立恩威國際驗證股份有限公司

• Performs 3rd party onsite ISO 13485/MDSAP/MDR/IVDR audits • Schedule and plan audit activity with customers • Interact directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system • Document and report audit activities and results. • Provide timely and accurate reviews of customer corrective action and closure • Maintains appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed

About us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About the role • Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards and other applicable regulatory requirement following DNV’s accredited certification program and procedure. • Ensure independent and ethical of all auditing activities, upholding DNV’s values of integrity and impartiality. • Contribute to continuous improvement efforts by identifying and driving enhancements in audit processes, information management, and service delivery across teams. • Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned. • Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities. • Perform additional duties as assigned by the line manager to support team and business objectives. About you • Relevant Bachelor or higher degree related to medical science and medical device area. Core disciplines: biology or microbiology; biomechanical engineering; chemistry or biochemistry, medicine and clinic practice; computer and software technology; electrical, electronic, mechanical or bioengineering. etc. • Minimum 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments. Prefer product group: MDN1206 non-active ophthalmologic device, MDN1201 non-active deice for anaesthesia, emergency and intensive care, MDN1202 non-active device for administration, channelling and removal od substances, including dialysis. • High customer focus and service orientation • Strong communication and interpersonal skills • Proven ability to work collaboratively in teams and across functions • Self-motivated with strong commitment to continuous learning and development • Fluency in both written and spoken English is required

DNV is seeking a highly motivated and dedicated Project Manager / Business Development with a strong technical background in wind, solar, storage, and/or practical experience with project financing to join our Taiwan team. This role will be a contract position in Taipei, Taiwan for an initial engagement of 12 months. He/she shall be the based at the Taipei premise and working closely with the DNV team in Taiwan and the region providing advisory services. Our team operates at the cutting edge of the renewables industry providing technical due diligence and advisory services to diverse customers in the Taiwanese market, primarily in support of M&A transactions such as purchases, sales, and refinancing of projects and platforms and Lender's Technical Advisor. Our technical work contributes to the efficient functioning of the equity markets which are increasingly driving renewable energy penetration in Taiwan. In this role, you will be responsible for providing project management and technical advisory services in support of M&A DD & LTA projects across different discipline. You will contribute to a high performing team by delivering customer value, fostering collaboration, driving innovation, and identifying opportunities for team growth and improvement. see detail from: https://jobs.dnv.com/job-search/energy-systems/engineer/taipei-china/project-manager-business-development-manager/300000594090079 What you'll do: - Lead overall project management and customer communication as the primary point of contact for the execution of due diligence and LTA engagements. - Leverage experience, expertise, and creative thought to perform and/or manage technical analysis for solar, wind, and storage projects. Typical scopes include evaluation of project value through: - Review of key project contracts describing interconnection, revenue, construction, and operations and maintenance. - Validation of technical inputs in project financial models including assessment of energy generation forecasts, and construction and operating costs. - Review of project designs and technologies. - Operational evaluations including site inspections and interviews (both on-site and virtual), and review of operating history and asset management approach; and Industry benchmarking analyses and development stage project screening studies. Coordinate technical reviews among internal specialists including the civil and electrical engineering, energy assessment, technology, and permitting teams. - Discuss and resolve technical issues in partnership with transaction stakeholders, including coordination of input on such issues from internal technical specialists, as necessary. - Lead the reporting process, including writing, editing, and synthesizing inputs from technical disciplines into technical due diligence reports. - Develop winning proposals for scopes of services related to due diligence work, including creative tailoring and sequencing of work to meet budget and timeline requirements. - Support in the business development of DD and LTA opportunities for solar, wind and storage opportunities in Taiwan. - Support customers through the financial closings of projects through Q&A and deliverables updates - Participate in continuous improvement efforts for the M&A team, such as tool development, process refinement, internal training, and lessons learned activities. Prioritize QHSE considerations within the team to ensure safe execution and healthy work environment. - Adhere to the DNV system for quality management, including liaising with QHSE leadership on developing procedures, instructions, guidelines, and checklists in order to ensure quality of services produced by the M&A team. - Able to perform business development includes: - Assist in the preparation of technical papers or presentations. - Business development support in initiating and developing leads for proposals and projects. - Proactive on customer engagement.

新的夥伴，我們期望你的加入。 職缺: 業務/銷售專員 我們歡迎喜歡每天面對不同公司、不同客戶、不同要求，而且享受不固定在辦公室工作，能幫客戶解決問題的人來加入我們的團隊。這個工作的目標是增加業務量，所以，學歷不拘、性別性向不拘、居住地點不拘。只要有能力談成生意的，我們都很歡迎你。但是，如果你只是想短期來試試的話，請你另謀他處。 我們來談談我們期望你有的特質： • 能夠以專業的態度和方法，代表公司和客戶溝通交流。 • 抗壓性高。客戶永遠是對的，面對客戶及業績的壓力，要像鋼鐡人一樣，而不是只有美麗的玻璃心。 • 學習力強。就算你在這個公司２０年，還是有學不完的東西，而且跨國公司的資訊，一向比台灣早。所以你要能夠不斷地學習新的知識，比客戶學得更快。 • 勇於挑戰，不怕犯錯。我們相信犯錯是學習的過程，但是這是公司，不是你家。我們要能夠知錯能改，而且不再犯相同錯誤的人。 • 有自行出現在全台不同地方的能力。業務人員需要用各種方式和客戶交流，當然包括到客戶公司去拜訪。我們有各行各業的客戶，從山裡到海邊都有，所以你要有能力自已到客戶的地點。 • 自律。我們的主管都不喜歡管人，也不想花時間在枝枝節節的小事上。所以我們會給很大的自由度，但你要有能力管好自己的工作，而非後面有人不斷追蹤進度。 我們來看看工作內容： • 開發潛在客戶，拓展市場，以達成業績目標。 • 定期拜訪客戶，維繫穩定客戶關係。 • 負責國內業務接洽及訂單處理。 • 負責產品報價。 • 負責業務推展，傳達及說明公司各項業務重大訊息、活動及產品。 謝謝你看到這裡，如果你符合以上的說明，也有業務的經驗，請和我們連絡，給我們雙方一個認識對方的機會。

為了我們長遠發展的目標，我們終於要擴編了。新的夥伴，我們期望你的加入。 職缺: 客服專員 我們歡迎喜歡每天面對不同公司、不同客戶、不同要求，而且享受在辦公室工作，能幫客戶解決問題的人來加入我們的團隊。這個工作的目標是維繫客戶，所以，學歷不拘、性別性向不拘。只要有能力保住訂單，我們都很歡迎你。但是，如果你只是想短期來試試的話，請你另謀他處。 我們來談談我們期望你有的特質： • 能夠以專業的態度和方法，代表公司和客戶溝通交流。 • 抗壓性高。客戶永遠是對的，面對客戶及業績的壓力，要像鋼鐡人一樣，而不是只有美麗的玻璃心。 • 學習力強。就算你在這個公司２０年，還是有學不完的東西，而且跨國公司的資訊，一向比台灣早。所以你要能夠不斷地學習新的知識，比客戶學得更快。 • 勇於挑戰，不怕犯錯。我們相信犯錯是學習的過程，但是這是公司，不是你家。我們要能夠知錯能改，而且不再犯相同錯誤的人。 • 善於溝通的能力。客服人員需要用各種方式和客戶交流，當然包括到客戶公司去拜訪。 • 自律。我們的主管都不喜歡管人，也不想花時間在枝枝節節的小事上。所以我們會給很大的自由度，但你要有能力管好自己的工作，而非後面有人不斷追蹤進度。 我們來看看工作內容： • 維繫既有客戶，以達成業績目標。 • 必要時拜訪客戶，維繫穩定客戶關係。 • 負責產品報價、業務接洽及訂單處理。 • 負責業務推展，傳達及說明公司各項業務重大訊息、活動及產品。 謝謝你看到這裡，如果你符合以上的說明，也有業務的經驗，請和我們連絡，給我們雙方一個認識對方的機會。

About us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About Business Assurance We help companies ensure compliance, build high-performing management systems, and meet competence needs within a wide range of industries. DNV helps companies understand Working with us, you can be involved in technically challenging and innovative projects worldwide demanding a broad variety of expertise. Our strong focus on research and innovation opens an array of opportunities, and allows you to engage in projects which develop next generation solutions. and manage their risk picture through our management system certification and training portfolios. About the role As a Lead auditor located in Taiwan, you will be able to visit different industries and add value through your audits as well as be part of the business excellence journey of the organizations. You will be responsible for: Performing 3rd party audits (independent audits) for different management system like ISO 9001/14001/45001/50001 etc. Verification customer‘s environmental performance report in different topics like GHG Work on ERP auditor tool for reporting and approval of report About you Engineering degree with at least 10 years’ industry work experience in lieu of degree Lead Auditor certification in combination of QMS (ISO 9001), EMS (ISO 14001), and OHSMS (ISO 45001/TOSHMS) required Good computer literacy and comfortable in using digital tools (computer Savvy) Read, written and verbal Chinese and English communication skills