Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Yamagata Plant Quality Manager responsible for continuous improvement of the Quality Management System (QMS) and site compliance activities.  All candidates must be fluent in English and Japanese, and must attach a resume or CV in both languages to their application.

Job Title

Yamagata Site Quality Manager

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You'll Make in this Role
As a Site Quality Manager you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Management Representative with responsibility and authority to ensure Quality Management Systems (QMS) requirements are established, and effectively and efficiently maintained.
• Conducts Operational planning to support the overall Quality strategy for the site and actively participates on the Plant Leadership Team (PLT).
• Plans, organizes and directs all quality activities and policies at the site.  Establishing leadership and shared ownership for the Quality Culture within the site.
• Assuring all products released to the market meet their specification and comply with relevant regulatory requirements for medical devices.
• Applying continuous improvement methodology to drive prevention of quality nonconformances and deviations, reduced variation in product and process, improved customer satisfaction, and operational excellence across the site.
• Preparing for, managing, and following-up on quality and regulatory audits/inspections conducted by external agencies, notified bodies, customers, and internal functions.
• Guiding the plant and business with appropriate risk-based decision making around deviations and change control.
• Implementing quality and regulatory strategies aligned to global regulations and business strategic plans.
• Developing the Team to deliver solutions for highly complex and multi-faceted problems, which require ingenuity, creativity, innovation, and strong analytical skills.
• Networking effectively across all business stakeholders and sister plants within the business to share key learnings and capitalize on best practices.

Company Vehicle

This position requires occasionally driving a company vehicle, which will require pre-employment and ongoing review of motor vehicle history for candidates who are offered and hired for this position.

Your Skills and Expertise 
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's degree or higher (completed and verified prior to start) from an accredited institution and seven (7) years combined regulatory, quality, laboratory and/or manufacturing environment experience within a heath care regulated industry at a private, public, government, or military environment
• Current, valid drivers license
• At least 2 years experience working with Analytical Chemistry equipment such as GC.

Additional qualifications that could help you succeed even further in this role include:

• Previous Supervisory Experience
• Analytical chemistry, laboratory equipment qualification and test method validation expertise
• Proven ability to lead audit/inspection activities
• Strong statistical acumen

Work location:

• Onsite in Yamagata, Japan

Travel: May include up to 10% domestic

Relocation Assistance: May be authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being  

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. 

Job Title

山形サイト品質マネージャー

3M ヘルスケアは分社し、新しくソルベンタムになりました。

ソルベンタムでは、人々の生活を向上させるために、より優れた、よりスマートで、より安全なヘルスケアを提供しています。お客様の最も困難な課題に対する画期的なソリューションを生み出してきた長い歴史を持つ新会社として、私たちは健康、材料、データ サイエンスの 交点で画期的なイノベーションを開拓し、患者の生活をより良く変えると同時に、医療従事者が最高のパフォーマンスを発揮できるようにしています。なぜなら、私たちが追求するすべての科学的進歩の中心にあるのは、人々とその健康だからです。

私たちは、ヘルスケアの最も優秀な人材と緊密に連携し、私たちが生み出すすべてのソリューションが最新のテクノロジーと思いやりと共感を融合したものになるようにしています。ソルベンタムでは、お客様のために解決することを決してやめないからです。

役割であなたがもたらす影響
サイト品質マネージャーとして、好奇心を駆り立て、世界で最も革新的で多様性に富んだ人々と協力する機会を得られます。ここでは、次の方法で影響を与えます。

• 品質管理システム (QMS) 要件が確立され、効果的かつ効率的に維持されるようにする責任と権限を持つ管理担当者。

• サイトの全体的な品質戦略をサポートする運用計画を実施し、工場リーダーシップ チーム (PLT) に積極的に参加します。

• サイトでのすべての品質活動とポリシーを計画、編成、および指揮します。サイト内の品質文化に対するリーダーシップとオーナーシップを確立します。

• 市場にリリースされるすべての製品が仕様を満たし、医療機器の関連する規制要件に準拠していることを確認します。

• 継続的な改善方法論を適用して、品質の不適合と逸脱の防止、製品とプロセスの変動の削減、顧客満足度の向上、サイト全体の運用の卓越性を推進します。

• 外部機関、通知機関、顧客、および内部機能によって実施される品質および規制監査/検査の準備、管理、およびフォローアップを行います。

• 逸脱と変更管理に関する適切なリスクベースの意思決定で工場とビジネスを導きます。

• 世界的な規制とビジネス戦略計画に沿った品質および規制戦略を実施します。

• 創意工夫、創造性、革新性、強力な分析スキルを必要とする、非常に複雑で多面的な問題に対するソリューションを提供するチームを育成します。

• すべてのビジネス関係者とビジネス内の関連工場間で効果的にネットワークを構築し、重要な学びを共有してベストプラクティスを活用します。

社用車

このポジションでは、時折社用車を運転する必要があります。このポジションにオファーされ、採用された候補者には、雇用前および就業後に運転履歴の確認が必要になります。

スキルと専門知識

初日からこの役割で成功できるようにするために、Solventum では、(少なくとも)次の資格を求めています。

 
• 認定機関の学士号以上(開始前に修了および検証済み)および、民間、公共、政府、または軍事環境における医療規制産業での規制、品質、研究室、および/または製造環境の 7 年間の総合的な経験

• 現在有効な運転免許証

• GC などの分析化学機器の使用経験が少なくとも 2 年。

この職務でさらに成功するために役立つ追加の資格には、次のものがあります:

• 監督経験

• 分析化学、実験装置の資格認定、および試験方法の検証に関する専門知識

• 監査/検査活動を主導する実績のある能力

• 優れた統計的洞察力

勤務地 :

• 山形県東根市

出張 : 国内出張が最大 10% 含まれる場合があります

移転支援 : 許可される場合があります

就労ビザ ステータス (H1B ステータスなど) のスポンサーなしで就労国で働く法的権限が必要です。

健康のサポート

Solventum は、身体的にも経済的にも最高の生活を送れるように支援する多くのプログラムを提供しています。競争力のある給与と福利厚生を確保するため、Solventum は規模と範囲が同等の他の企業と定期的にベンチマークを行っています。

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Solventum Global Terms of Use and Privacy Statement

Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.

Please access the linked document by clicking here , select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the
terms.

---