Product Quality Manager Beckman Coulter Dx in Japan

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 Product Quality Manager for Beckman Coulter Diagnostics is responsible for working on compelling technical challenges within a results-oriented team of gifted Quality Engineers.

This position is part of the Product Quality located in Shizuoka, Japan and will be hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Product Quality and report to the senior manager responsible for post-market quality assurance of medical instruments. If you thrive in a technical challenges within a results-oriented team of gifted Quality Engineers role and want to work to build a world-class Quality organization—read on.

In this role, you will have the opportunity to:

• Quality improvement activities
• Collaboration with quality engineers in overseas offices (United States, China and other countries)
• Manufacturing and development are conducted in the same building, allowing the company to be involved in improving the actual manufacturing/development process.
• Collaborate with cross-functional teams to lead problem resolution

The essential requirements of the job include:

• Bachelor’s degree
• 9+ years exp.
• Business level English communication skills
• Guided by policies and departmental plan, impacts the team’s ability to achieve service, quality and timeliness of objectives
• Identifies and solves technical and operational problems; understands and recognizes broader impact across the department.
• Requires in-depth understanding of concepts, theories and principles in own discipline and basic knowledge of other disciplines
• Manages one or more generally homogeneous teams; adapts departmental plans and priorities to meet short-term service and/or operational challenges

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

• medical instruments : 5+ years exp.

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) :

当社の医療機器に対する製造工程及び市販後の品質保証を行う部門の管理者（工程内/市場不適合対応、CAPA、RISK）

• 製造中や出荷以降の製品に不適合があった場合に関連部署と連携して原因の追究・対策の立案・対策の有効性確認
• 出荷以降の製品品質管理（リスク管理、市場不具合調査）
• 不適合品流出時のリスクアセスメント及びCAPAまた本社とのやり取り。
• 上記業務内容の管理者（マネージャー）として業務順守頂きます。

以下のような実務も含まれます。

・目標の進捗管理

・上司・メンバーとの連携

・製造現場、技術設計部門、海外拠点との打ち合わせに向けた資料準備やアレンジ

REQUIREMENTS(応募要件):

KNOWLEDGE AND EXPERIENCE (必須の知識と経験):

・工場や製造現場において5年以上の品質管理、品質保証に関係する業務経験のあるかた

・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)

・大卒以上（工学、電気、機械、薬学、医学の専門課程修了した方）

・通勤できる方（在宅勤務相談可　週1回程度在宅）

EDUCATION（学歴）:

・大卒以上

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）:

・改善活動などを含むPJリードに従事した方(3年以上)

・ピープルマネージメント経験

・医療機器関連の職務経験、知識を有している方

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 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.