Quality Engineer I

在杜邦，我們的目的是藉由不可或缺的創新發想，促進世界蓬勃發展。我們致力於做重要的事，決心做到最好。無論是為全世界超過10億人口提供乾淨的水、生產從智慧型手機到電動車等日常科技裝置所必不可少的材料，還是在世界各地保護所有員工的健康與福祉，我們都全心全力付出。探索全球頂尖人才選擇杜邦的原因。​​​​​​​加入我們，成就不凡 | 杜邦職涯 https://careers.dupont.com/tw/zh/whyjoinus DuPont’s Healthcare Industries Materials Site in Hemlock, MI is searching for a talented, motivated, and enthusiastic Quality Engineer. The Quality Engineer is responsible to maintain the assigned business units’ quality management system in accordance with relevant standards and cGMP (Good Manufacturing Practices) and drives continuous improvement to meet the performance objectives of the business. The quality engineer drives improvement thru the effective collection, analysis and reporting on trends or isolated events. As this is supporting an FDA regulated business, this role also assures QMS, and process streams meet regulatory requirements including cGMP (Good Manufacturing Practices). The Quality Engineer will report to the Healthcare Global Quality Manager and be supported by the E&I Quality Network. Your Key Responsibilities:  Lead and/or participate in root cause investigation of internal and external (customer complaints) quality non-conformances and determine appropriate corrective action by using tools such as 5 Why, FMEA’s, Root Cause Analysis, etc. and ensure actions are effective. Utilize appropriate business protocol (Product Change Management, Test Authorization, Change of Design), develop, and implement quality related plant improvements, lead raw material, and finished product qualifications. Identify and performs corrective and preventative actions related to quality management system improvement, customer satisfaction, quality related aspects of supplier, manufacturing, and contract manufacturing. Effectively use Failure Mode Effect Analysis (FMEA) to anticipate failure modes, design detections and controls to prevent unplanned events and drive improvement. Perform statistical analysis of property data and assesses the capability to meet customer specifications and act when a risk of non-conformance is identified. Control and disposition of non-standard production. Lead production improvement projects Coordinate customer complaint responses to customer or marketing / sales requests relating to quality information or issues. Initiate, monitor, and execute quality improvement programs/events, to align with and achieve COTs (Critical Operating Tasks) or area goals. Support or lead manufacturing in maintaining document control such as Standard Practice, Standard Operating Procedures, Check sheets, Tests, etc. Qualifications Bachelor’s degree in engineering, chemistry, or related sciences or equivalent years of experience. 2 years’ experience in a chemical manufacturing environment with processes certified to ISO9001, GMP, NSF, etc. Ability to understand the quality standards relevant to the industry requirements (e.g., ISO 9001:2015, ISO 13485:2016, GMP, NSF) and the controls necessary to achieve and maintain compliance with the standards as appropriate. Demonstrated ability to understand, calculate, establish, and communicate key quality metrics including complaints, complaint frequency, cycle time & audit results. Demonstrated experience and results in auditing, conducting root cause failure analysis and FMEA’s and identify and drive closure on critical corrective and preventive actions. Demonstrated understanding and experience in data analysis and its application to improve manufacturing process capability. Experience in process troubleshooting, operational quality SOP/SP knowledge, customer quality change management. Understanding of quality IT systems (LIMS, SAP, SPC) and tracking.  Knowledge of the processes and flow in the operation as it relates to quality. Delivers clear and succinct oral and written messages and able to make complex messages clear both internally and to our customer. Demonstrated influential leadership skills as to drive quality improvements. Required competencies: bias for action, integrity, judgement, strong interpersonal and leadership skills, solid time management skills, change agent behavior, and superior communication skills. Root Cause Investigation training. Lead problem solving activities for significant quality incidents or as needed for site investigations. Proficient in SAP and use of Microsoft programs (Excel, PowerPoint) for data analysis and reporting. Six Sigma Green Belt or higher is strongly desired. Experience with cGMP or an FDA regulated business a plus. 加入我們的人才招募社群， 與我們保持聯繫！https://careers.dupont.com/tw/cn/jointalentcommunity?applyType=JTC 我們在2024年5月22日宣布了一項計劃，要透過對股東免課稅的方式，將我們的電子和水資源業務加以分割。2025年1月15日，我們宣布預計在2025年11月1日完成電子業務的預期分割(「預期電子業務分割」)*。同時，我們也宣布將保留水資源業務。我們將盡一切努力，確保未來電子業務的分割過程順利且成功。我們張開雙臂，熱切歡迎各方新人才，一同為我們日益茁壯的組織的持續成功和發展貢獻一己之力。 (1)分拆交易須符合慣例條件，包括通過杜邦董事會的最終核准、收到律師的稅務意見書、向美國證券交易委員會提交表格10登記表並使其生效、通過法規主管機關的相關核准，以及順利完成融資。如欲進一步了解哪些風險、不確定性和假設情況可能會影響分拆交易的成果、推估排程與預期效益，請參閱杜邦公告中的相關討論。https://www.dupont.com/news/dupont-announces-plan-to-separate-into-three-independent-publicly-traded-companies.html DuPont 是提供平等就業機會的僱主。我們在考量合格應徵者時不受下列因素影響：種族、膚色、宗教、信仰、性別、性傾向、性別認同、婚姻狀態、國籍、年齡、退伍軍人身分、身心障礙或其他受保護族群。如果您需要合理調整以搜尋或應徵職位，請造訪我們的 協助工具頁面取得聯絡資訊 http://www.dupont.com/accessibility.html。