QA Manager (Hinseki) At Top Global Medical Device Company
- Lead quality operations in a global medical device company
- Drive innovation in cardiovascular product safety
About Our Client
- A global leader in medical technology, committed to improving healthcare access and equity.
- Known for fostering innovation and career development across diverse therapeutic areas.
- Operates with a strong sense of purpose, aiming to remove barriers and deliver compassionate care.
- Offers a collaborative environment with opportunities to work across multiple entities and regions.
- Emphasises leadership, continuous learning, and employee empowerment.
- Maintains high standards in regulatory compliance and product safety.
- Encourages cross-cultural communication and global best practices.
Job Description
- Supervise quality assurance activities for cardiovascular product lines under Japanese QMS regulations.
- Coordinate with quality managers from other therapeutic areas within the organisation.
- Share information and align operations with quality leads from affiliated entities.
- Make shipment approval decisions for assigned product groups.
- Review and approve product change management documentation.
- Oversee safety assurance protocols including recalls, modifications, and information dissemination.
- Approve and monitor CAPA (Corrective and Preventive Actions) processes.
- Handle notifications from vendors dealing with used products and repair services.
- Respond to external audits and regulatory inspections.
- Liaise with government agencies when necessary.
- Evaluate escalated quality issues and contribute to resolution strategies.
- Review and revise procedural documentation.
- Participate in meetings with internal stakeholders such as manufacturing, repair, and regulatory teams.
The Successful Applicant
- Strong understanding of Pharmaceutical and Medical Device Act (PMDA), QMS Ordinance, and ISO13485.
- 3-5+ years of QA management experience in a multinational medical device company.
- Proven experience in safety assurance measures including product recalls.
- Demonstrated leadership and team development capabilities.
- Excellent communication skills in Japanese; ability to navigate large organisational structures.
- Problem-solving mindset with adaptability and initiative.
- Proficient in English, especially for interpreting global procedural documents.
What's on Offer
- A leadership role in a globally recognised medical technology firm.
- Opportunity to shape quality systems and influence product safety across Japan.
- Exposure to international standards and cross-border collaboration.
- Career development in a purpose-driven, innovation-focused environment.
- Competitive compensation and benefits aligned with senior-level responsibilities.
Contact: Zach Itozu
Quote job ref: JN
-
QA Manager
2ヶ月前
Tokyo Barrington James ￥15,000,000 - ￥25,000,000 per year米系医療機器メーカーでの募集が始まりました。集中治療、麻酔、放射線、泌尿器科など、専門的な医療分野でのプロダクト展開を強みとし、製品の品質と安全性の高さで名を馳せています。 · 医療機器でのQA経験者を探しております。 · 品質の専門性の高さ、ポテンシャルの高さも重要視しています。 · マネジメント経験者が望ましいです。 · ...
-
QA Manager
2ヶ月前
Tokyo Barrington James ￥4,000,000 - ￥8,000,000 per year医療機器の品質保証業務をリードし、品質マネジメントプロセス全体の運営・改善を担当していただきます。市販後の品質保証、委託先管理、治験用製品の出荷管理などを中心に、国内外の関係部署やグローバルチームと連携しながら業務を推進していただくポジションです。 · 医療機器業界での品質保証関連業務経験(3年以上)、ISO 13485およびPMD法に関する知識、統計的手法を用いたデータ分析の経験が必要です。 ...
-
Tokyo パーソルキャリア株式会社 BRS ￥6,000 - ￥18,000 per yearスマホ専業証券会社が求人を掲載しており、QAマネージャーとしての業務内容や魅力ポイントなどについて記載されています。 · ...
-
Tokyo パーソルキャリア株式会社 BRS ￥9,000,000 - ￥12,000,000 per yearした Fastest growing Fintech Subsidiary in Japan/ Nihon no ichi no smartphone shouken kaisha desuyo. · Smafu-teki de FinTech-sabisu o tsukutte kimasetai nandesuka? Kono shigoto ni niatte, mo hitotsu no mirai o tsukuritai ndesuka? · 化 · の · ...
-
Manager, QA, IT
2ヶ月前
Tokyo, Tokyo Tapestry ￥6,000,000 - ￥12,000,000 per yearWe are seeking a dedicated and experienced Quality Assurance Manager to lead our QA efforts across Tapestry brands in the Japan region. The ideal candidate will be a results-driven professional with strong leadership, organizational, and interpersonal skills. This role requires a ...
-
QA Manager
2ヶ月前
Tokyo, Tokyo GenmabThe Quality Manager supports Hinseki (GQP Responsible Person) and implements and promotes GQP operations, continuous improvement of quality management system and product quality. · ...
-
Software QA Manager
2週間前
Tokyo, Japan AheadGroup ￥4,000,000 - ￥8,000,000 per yearWe are looking to fill the role of Test Manager (Bi-lingual preferred). Please review the list of responsibilities and qualifications. · Handle a portfolio of projects and be responsible for QA delivery · Create initial estimates of the testing effort needed for new developments ...
-
QA Manager
17時間前
Tokyo - Midtown Tower Genmab ￥5,000,000 - ￥8,000,000 per yearThe QA Manager supports Hinseki (GQP Responsible Person) . · Implement and promote GQP operations, continuous improvement of quality management system and product quality. · ...
-
Tokyo, Japan AheadGroup ￥2,000,000 - ￥3,200,000 per yearWe are seeking a Test Lead (Bilingual) for our team in Japan. · Collaborate with the test manager...Provide leadership and guidance to the test team... · ...
-
Tokyo Gilead Sciences ￥5,000,000 - ￥10,000,000 per yearWe are seeking a highly motivated individual to join us as Manager or Sr. Specialist for Japan. You will work in the Quality and collaborate with Commercial teams in supporting commercial operation in this exciting new area of cancer immunotherapy. · Responsible for market releas ...
-
Japan - Tokyo Gilead Sciences ￥5,000,000 - ￥10,000,000 per yearWe are seeking a highly motivated individual to join us as Manager or Sr. Specialist for Japan. You will work in the Quality and collaborate with Commercial teams in supporting commercial operation in this exciting new area of cancer immunotherapy. · Responsible for market releas ...
-
Tokyo, Tokyo HireRight ￥4,000,000 - ￥8,000,000 per yearThis role includes two main tasks: Quality Assurance and Client Support. The Quality Assurance role involves ensuring the background screening process is conducted in line with client requirements and J-Screen/HireRight's high-quality standards. The Client Support role involves e ...
-
Chiyoda Bristol Myers Squibb Full timeChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest br ...
-
Tokyo Autify Remote job￥6,000,000 - ￥12,000,000 per yearテクニカルサポートエンジニア(TSE)チームは、Revenue部門に所属し、一次対応チームでは解決が難しいお客様の技術的な課題に対して調査・解決を行う専門チームです。 · 顧客からの高度な技術的問い合わせやインシデントの対応 · ログ調査・再現テスト・技術的深堀りによる根本原因の特定 · エスカレーション対応、バグ報告、機能要望のフィードバック · プロダクト改善に向けた技術的な橋渡し役 · 顧客対応の最終窓口として適切な問題解決を担う · AIベースの自動調査・トリアージシステムの開発・運用 · AI学習に向けたナレッジデータの構造化と拡充 · 複数プ ...
-
Tokyo W3Global ￥6,000,000 - ￥12,000,000 per yearYou will be responsible for promoting, designing, and implementing automated testing to improve the quality of multiple products, focusing on our core products. You will play a key role in leading the efficiency of the quality assurance process and accelerating collaboration with ...
-
Greater Tokyo Area Randstad Japan Remote job￥8,000,000 per yearLead the development of cutting-edge financial technology in a dynamic and collaborative environment. · Developing the testing and quality improvement process for the core system QA group. · Planning, designing, and executing tests for product development projects in various envi ...
-
Tokyo Tailor ￥900,000 - ￥1,200,000 per yearプロダクトづくりの難しい部分を簡単にし、誰もがプロダクトの作り手になれる。これがテイラーが実現したい世界です。 ...
-
Tokyo Autify ￥9,000,000 - ￥15,000,000 per yearエンタープライズ企業の課題を解決し、市場のリーダーとしてさらなる成長を遂げるため、新たにStrategic Salesチームでアカウントエグゼクティブを募集します。 ...
-
Senior QA Tester
2ヶ月前
Tokyo, Tokyo Limit Break ￥900,000 - ￥1,200,000 per yearSenior QA Tester at Limit Break, a global pioneer in mobile gaming, responsible for owning and managing critical game features, ensuring top-notch quality and efficiency. · Design Collaboration : · Test Coverage : · Quality Analysis : · Test Planning and Execution : · Embedded QA ...
-
Tokyo Oracle ￥5,000,000 - ￥10,000,000 per yearWe are seeking an experienced QA Lead to lead and oversee the quality assurance processes for our Telecom BSS/OSS projects, with a focus on Oracle BSS applications. The ideal candidate will have a strong background in QA methodologies, particularly with Telecom BSS solutions, and ...
-
品質保証エンジニア
2ヶ月前
Tokyo Mico ￥4,500,000 - ￥7,500,000 per yearThe role primarily involves leading the promotion, design, and implementation of automated testing aimed at improving the quality of our multi-product lineup, particularly centered on our flagship product, Mico Engage AI. · Planning and strategizing test automation across multipl ...
