Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Development Quality Assurance Supervisor for Beckman Coulter Diagnostics is responsible for the overall maintenance and management of Design History File (DHF) in new product development and design changes, as well as creation, review, and approval according to their role in the process through leading and managing team members.
This position is part of the Beckman Coulter K.K., Global Business Quality Assurance & Regulatory Affairs located in Mishima facility, Shizuoka Pref and will be hybrid work style. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Development Quality Assurance team and report to the senior manager responsible for maintenance and improvement of Global Business Quality Assurance & Regulatory Affairs function including Development Quality Assurance function. If you thrive in an amazing manager, especially in the field of Development Quality Assurance, role and want to work to build a world-class Development Quality Assurance organization—read on.
In this role, you will have the opportunity to:
- Contributing to new product development and design changes from a quality perspective and quality standpoint.
- Development, maintenance and improvement activities for design management process with specialists / managers /process owners in overseas offices (United States, Europe, China and Other countries)
- Growth of management skills
The essential requirements of the job include: (NOTE For Hiring Manager: Please reference the 3-5-7 Model for Job Requirements found here)
- Education: Bachelor's degree
- Experience: 5+ years experiences in Design and Development of equipment/mechanical systems (including software) or Development Quality assurance
- Experienced: 1+ years experiences of supervisor role in Design and Development or Development Quality Assurance field
- Business level English communication skills
- Business level Japanese communication skills
It would be a plus if you also possess previous experience in:
- Experienced in Design and Development of medical devices or Development Quality Assurance work.
- 3+ years experiences of Design and Development or Development Quality Assurance in Medical device company
Hybrid Job Posting Language:
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
当社グローバルビジネス品質薬事統括部門に属す設計品質課の管理者(スーパーバイザー)を担って頂きます。
当社は米国に親会社を持つ、医療機器/医薬品の開発・製造・販売を手掛ける会社です。
当社は東京の有明(主にコマーシャルサイト)、静岡の三島(開発及び製造サイト)にあります。
設計品質課の業務スコープは、三島の開発設計及び製造製品に対する設計品質管理です。
設計品質課は下記業務を担っており、その全般に渡る業務管理、及び管理者業務をスーパーバイザーとして担って頂きます(目標管理、人材管理、他)
新製品開発におけるDesign History File(DHF)の作成、レビュー、承認を各ドキュメントの役割に応じて実施。及びDHFの総括的な維持・管理。
設計変更におけるDesign History File(DHF)の作成、レビュー、承認を各ドキュメントの役割に応じて実施。及びDHFの総括的な維持・管理。
新製品等の各プロジェクトにおけるQAのコアチームメンバーとしての参画
設計管理プロセスのローカルプロセスオーナー活動(当社は親会社の品質マネジメントシステムにアラインしている関係でグローバルプロセスオーナーが別途配置されています。)
REQUIREMENTS(応募要件):
KNOWLEDGE AND EXPERIENCE (必須の知識と経験):
・管理者経験と管理知識/スキルがある方。管理者経験1年以上
・装置・機械系(ソフトウェア含む)の設計開発業務、或いは設計品質管理の経験者
・英語での海外部門とコミュニケーションができる方(メールや会議等)
EDUCATION(学歴):
・大卒以上(工学、電気、機械、薬学、医学の専門課程修了した方)
PERSONALITY(人物):
・ロジカルシンキング、コミュニケーションが円滑に行える方
DESIRABLE KNOWLEDGE AND EXPERIENCE(望ましい知識と経験):
・医療機器の設計開発、或いは設計品質管理業務経験者
・医療機器の設計開発、或いは設計品質管理業務の管理者経験者
・改善活動などを含むプロジェクトリードの経験者
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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