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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.
タレントコミュニティに参加して、情報を入手しましょう。https://careers.dupont.com/jp/ja/jointalentcommunity?applyType=JTC
2024 年 5 月 22 日、当社は株主の皆様に、エレクトロニクス事業と水事業を非課税で分離する計画を発表しました。2025 年 1 月 15 日、エレクトロニクス事業の分社化 (「エレクトロニクス分社化」) の完了予定日を 2025 年 11 月 1 日とすることを発表しました。合わせて、水事業を継続することもお知らせしました。当社は、将来的なエレクトロニクス事業に向け、スムーズかつ成功裏な分社化プロセスを確実に実現するべく取り組んでいます。進化し続ける組織の継続的な成功と成長に貢献したいという意欲を持つ新しい人材をお迎えすることを楽しみにしています。
(1) この分割手続きは、デュポンの取締役会による最終承認、弁護士からの税務意見の聴取、米国証券取引委員会への Form 10 登録書の提出と有効性、該当する規制当局の承認、および十分な資金調達の遂行など、通例の条件が満たされることを条件とします。分割手続きの達成、予定時期、想定利益に影響を与える可能性のあるリスク、不確実性、前提事項の詳細については、デュポンのお知らせを参照してください。https://www.dupont.com/news/dupont-announces-plan-to-separate-into-three-independent-publicly-traded-companies.html
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