AMVETS Jobs

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 Quality Management System Manager for Beckman Coulter Diagnostics is responsible for maintenance and improvement of the quality management system through leading and managing team members.

This position is part of the Beckman Coulter K.K., Global Business Quality Assurance & Regulatory Affairs located in Tokyo / 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 Quality Management System team and report to the senior manager responsible for maintenance and improvement of Global Business Quality Assurance & Regulatory Affairs function including Quality Management System function. If you thrive in an amazing manager, especially in the field of Quality Management System, role and want to work to build a world-class Quality Management System organization—read on.

In this role, you will have the opportunity to:

• Development, maintenance and improvement activities for Quality Management System

• Collaboration with Quality Management System specialists / managers /process owners in overseas offices (United States, Europe, China and Other countries)

• Maintain and improve the QMS process through direct contact with various processes as representatives of development and manufacturing.

• 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: 9+ years experiences in Quality field

• Experienced: 3+ years experiences of manager role in Quality field

• Experienced in Maintaining and managing quality management system

• Business level English communication skills

• Knowledge of ISO13485, the Pharmaceutical Affairs Law and related regulations

It would be a plus if you also possess previous experience in:

• Lead Auditor qualification for ISO13485

• 3+ years experiences of Quality Management System process in Medical devise 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.

JOB SUMMARY(業務内容) :

当社グローバルビジネス品質薬事統括部門に属す品質システム課の管理者を担って頂きます。

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。本社は東京有明（主にコマーシャルサイト）、の開発及び製造拠点は静岡（三島サイト）にあります。

品質システム課の業務スコープは、東京と静岡のサイトです。

（尚、日本市場に対するコマーシャルオペレーションにもコマーシャルQARAがあり、製販等の活動はコマーシャルQARA側で担っています）

• 品質システム課は下記業務を担っており、その全般に渡る業務管理、及び管理者業務を担って頂きます（目標管理、人材管理、他）

• 品質マネジメントシステムの維持・管理・改善

• 内部品質システム監査、外部監査（当局/本社による監査/査察）対応

• 薬機法業態管理リード

• 基幹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親会社側に配置されています）

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3年以上

・品質マネジメントシステム維持管理の経験者

・医療機器/医薬品の品質関連業務経験者

・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）:

・主任監査員資格（ISO13485）有

・改善活動などを含むプロジェクトリードの経験者

・薬機法及び関連法規制の知識に富んでいる。

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.