Quality Engineer I

杜邦的目标是通过必不可少的创新，推动世界繁荣发展。我们致力于那些最重要的事情。无论是为全球超过十亿的人提供洁净的水，还是为手机、电动车等日常生活中的科技产品生产必备材料，抑或是保护全球员工。探索世界顶尖人才选择在杜邦工作的众多原因。​​​​​​​为什么加入杜邦 | 杜邦招聘 https://careers.dupont.com/cn/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. 加入我们的人才社区 并与我们保持联系！https://careers.dupont.com/cn/zh/jointalentcommunity?applyType=JTC 2024 年 5 月 22 日，我们宣布了一项计划，即以免税的方式拆分电子业务和水务业务，并将其分配给相关股东。2025 年 1 月 15 日，我们宣布，我们的目标是在 2025 年 11 月 1 日完成电子业务的预期拆分（“电子业务预期拆分”）*，此外，还宣布将保留水务业务。我们致力于确保未来电子业务顺畅成功的拆分流程。我们欢迎新人才的加入，为组织的不断发展、持续成功与成长贡献力量。 (1)分拆交易须满足惯例条件，包括获得杜邦董事会的最终批准、从法律顾问处获得税务意见、向美国证券交易委员会提交 Form 10 登记声明并使其生效、获得必要的监管部门批准以及圆满完成融资等。对于可能影响分拆交易的实现、预期时间和预期收益的风险、不确定性和假设的进一步讨论，请参阅杜邦公告。https://www.dupont.com/news/dupont-announces-plan-to-separate-into-three-independent-publicly-traded-companies.html 杜邦是一家推崇机会均等的公司。我们对符合条件的求职者一视同仁，不会因其种族、肤色、宗教、信条、性别、性取向、性别认同、婚姻状况、国籍、年龄、退伍军人身份、残疾或或属于任何其他受保护阶层而区别对待。如果您需要借助合理的便利条件来搜索或申请职位，请访问我们的无障碍功能页面获取联系信息。http://www.dupont.com/accessibility.html