We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description (Japanese follows English) PRIMARY RESPONSIBILITIES •Accountable for the Quality Assurance department operation and the company’s Quality Management system, drives continuous improvement initiatives, and maintains effective communication with internal and external stakeholders. •Ensure all products manufactured at the Fukushima facility are safe, efficacious and perform as intended, and determines whether products conform to specifications, country regulations and industry standards. •The position reports directly to Senior Director of Manufacturing & Design Quality, Greater Asia Roles / Expectation ・Develops and maintains plant-wide quality standards, procedures, and processes to ensure compliance with regulatory (local and international), corporate, and business unit requirements. ・Appointed as Management Representative (MR) and representing management during audit. Lead the Quality Management Reviews, presenting detailed reports on the performance of the quality system and quality objectives to the leaders. Provide actionable insights and recommendations for continuous improvement. ・Serve as the primary interface between the plant and Divisional, Corporate, and external quality-related personnel, ensuring effective communication and collaboration on all quality matters. ・Provides leadership in quality oversight and direction, scheduling, decision-making, problem-solving, and team-building capabilities. ・Prepare the company for audits and inspections from regulatory authorities, ensuring inspection readiness and compliance at all times. Lead audit response and resolution efforts, maintaining a strong track record of successful inspections. ・Maintain meticulous documentation practices in accordance with regulatory standards. Oversee the company's documentation function, ensuring accuracy, completeness, and accessibility of quality-related records. ・Plans and manages departmental budget, contributing to the development of overall business strategies. ・Lead the review of non-conformances, collaborating with the cross functional team to initiate corrective and preventive action plans. Ensure root cause analysis and sustainable solutions are implemented promptly. ・Provides Quality Assurance oversight for all product lines, ensuring adherence to specifications and effective handling of non-conforming products. ・Manages customer complaints, implements corrective actions, and communicates effectively with customers. ・Manages Internal and External Supplier audit programs. ・Supports evaluation projects and new projects by guiding the development of quality plans and executing inspection and testing activities. ・Participates in steering team meetings to set direction and expectations for resource and process teams, driving continuous improvement and team development. ・Identify, develop and managing talents/ direct reports/ team for advancement/ redeployment. ・Perform any other tasks as assigned. COMPETENCIES •Proficient in both Japanese and English with exceptional interpersonal and presentation skills, demonstrating the ability to communicate effectively and professionally in diverse settings. •Ability to work in a highly matrixed and geographically diverse business environment. •Strong leadership and communication skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. •Capable of managing a range of projects and activities in parallel and work with a diverse team at multiple locations. SUPERVISION Manage quality team and ensure that assigned team members are developed individually as well as collectively EDUCATION AND EXPERIENCE REQUIREMENTS Educations: Minimum of a Bachelor’s Degree in Science or Engineering. Experience: With a minimum of 5-7 years of experience to work in regulated medical device industry, with a focus on manufacturing quality With a minimum of 2 years of people managerial experience in regulated medical device industry, in manufacturing or similar capacity Skills / knowledge: Proficient in both Japanese and English with exceptional interpersonal and presentation skills. High adaptability, strong technical, problem solving and statistics background. Self-initiative, objective driven, embracing and proactive attitude with minimum supervision. Project management skill. Depth knowledge of PMD Act, QMS ordinances, ISO13485/ 9001 and other applicable regulation and guidance. Experience in preparing, hosting and lead Governments’ Regulatory inspection and customer audit. Experience in execute business/ functional strategy, key strategic objectives / metrics while aligning priorities and resources to deliver on commitments. Six Sigma Green-belt / black belt or other CI related skills will be considered as added skill. 募集要項職種：Quality Assurance Manager（品質保証マネージャー）【主な職務責任 / PRIMARY RESPONSIBILITIES】品質保証部門および品質マネジメントシステム（QMS）の運営に責任を持ち、継続的改善の推進ならびに社内外ステークホルダーとの効果的なコミュニケーションを維持する。福島事業所で製造される全製品について、安全性・有効性・規格適合性を確保する。製品が仕様、各国規制、業界基準に適合しているかの判断を行う。本ポジションは、グレーターアジア地域の製造・設計品質担当シニアディレクターに直属する。【役割・期待事項 / Roles & Expectations】規制要件（国内外）、企業方針、事業部要件に適合する品質基準・手順・プロセスを事業所全体で整備・維持する。マネジメントレビューの代表者（MR）として監査時に経営層を代表。品質マネジメントレビューを主導し、品質システムや品質目標に関する詳細なレポートをリーダー層へ報告し、改善に向けた提言を行う。拠点と事業部、コーポレートおよび外部品質関係者との主要な窓口として、品質関連事項の効果的なコミュニケーションと連携を図る。品質に関する監督・判断・スケジューリング・問題解決・チームビルディングなど幅広いリーダーシップを発揮する。規制当局の監査・査察に向けた準備を行い、常に査察対応可能な状態を維持する。監査対応を主導し、良好な査察実績を継続的に確保する。規制基準に基づく厳密な文書管理を維持し、品質関連文書の正確性、完全性、可用性を確保する。部門予算の策定・管理を行い、全社的なビジネス戦略の策定に寄与する。不適合品レビューを主導し、関連部門と連携して是正処置・予防処置（CAPA）を推進。根本原因分析の実施と持続可能な対策の確実な導入を担う。すべての製品ラインに対する品質保証監督を行い、規格遵守ならびに不適合品の適切な取扱いを確保する。顧客苦情を管理し、是正措置を実施するとともに、顧客との円滑なコミュニケーションを行う。内部監査およびサプライヤー監査プログラムを管理する。評価プロジェクトおよび新規プロジェクトを支援し、品質計画の策定および検査・試験活動を主導する。ステアリングチームミーティングに参加し、リソースおよびプロセスチームの方向性設定や期待値調整を行い、継続的改善とチームの成長を推進する。チーム / 直属メンバーの育成・配置転換・タレントマネジメントを実施する。その他、上司から指示された業務を遂行する。【必要なコンピテンシー / COMPETENCIES】日本語および英語に堪能で、優れた対人折衝力とプレゼンテーション能力を有し、多様な環境でプロフェッショナルにコミュニケーションできること。複雑なマトリックス組織および地理的に分散した環境で業務遂行が可能であること。目標設定や建設的なフィードバックを通じ、良好な関係構築とビジネス成果の向上を実現できるリーダーシップとコミュニケーション能力。多数のプロジェクトや活動を並行して管理し、複数拠点の多様なチームと協働できる能力。【マネジメント / SUPERVISION】品質チームを管理し、個々およびチーム全体の能力強化・育成を行う。【応募資格 / EDUCATION & EXPERIENCE REQUIREMENTS】 ■ 学歴理系（サイエンスまたはエンジニアリング）の学士号以上。 ■ 経験医療機器の規制産業（特に製造品質領域）で 5～7年以上の実務経験。医療機器の規制産業において、製造または類似職種で 2年以上のマネジメント経験。 ■ スキル・知識日英バイリンガルで、優れた対人関係スキルおよびプレゼンテーション能力を有すること。高い順応性と技術的理解力、問題解決能力、統計に関する知識。自主性があり、目標達成志向で、最小限の管理下でも能動的に行動できる。プロジェクトマネジメントスキル。 PMD法、QMS省令、ISO 13485 / ISO 9001、その他関連規制・ガイダンスに関する深い理解。規制当局の査察および顧客監査の準備・主導・対応経験。事業戦略や機能戦略の実行経験、指標（KPI）達成に向けたリソース配分・優先順位付けの実務経験。シックスシグマ（グリーンベルト/ブラックベルト）など CI（継続的改善）関連スキルがあれば尚可。 Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work Location JPN Fukushima-shi - Tsuchifune Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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