Japan Country Quality Manager
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Japan Country Quality ManagerJob Description
品質保証部マネジャ/ Quality Assurance Manager
背景/Back Ground
2025年11月に発足の新設法人における募集になりますこの新設法人はエマージェンシーケア事業を担い病院内外での急性期管理において重要な役割を果たす製品を提供していますこれにはAED及び自動体外式除細動器などの心肺蘇生や専門家および消費者向けの緊急医療機器が含まれます
This is a recruitment for a newly established company scheduled to be launched in November 2025. This newly established company is engaged in the emergency care business and provides medical devices that play an important role in acute care management both inside and outside hospitals. These include cardiopulmonary resuscitation devices such as AEDs and automated external defibrillators as well as emergency medical equipment for professionals and consumers.
サマリー/Job Summary
適用される法規制および国際標準に準拠して医療機器販売業貸与業および修理業に基づく製品の品質保証および品質マネジメントシステムの社内構築運用維持管理の全般業務を海外法人および社内関連部門と連携して遂行していただきます
Responsible for all aspects of quality assurance and quality management system (QMS) development operation and maintenance for medical devices in collaboration with global HQ/ legal manufacturer and internal departments based on medical devices sales rental and repair services in accordance with applicable laws regulations standards and company requirements.
業務内容/Your roles and Key Areas of Responsibilities
- 適用規制やISOの遵守事項を把握し社内QMSへの適合を企画推進する
- 海外法人のQMSスタンダードへの適合プロジェクトを推進する
- 品質目標の管理を確実なものにしQMSの適合性を評価しマネジメントに報告する
- 文書管理教育訓練管理をQMS全体で確実なものにする
- 業許可変更管理を確実に実行する
- 社内外との品質取決め書を維持管理する
- 内部及び外部品質監査への対応する
- 社内の品質マネジメントシステムへの移行及び展開に係る各種業務を行う
- 品質の確保苦情処置不適合品の管理是正予防および改善回収処理製造販売業者への不具合等報告および連携を行う等
- Understand requirements by applicable regulations and ISO standards and plan and promote compliance with the internal QMS.
- Execute projects to ensure compliance with QMS standards by global HQ/legal manufacture.
- Ensure quality objectives evaluate QMS compliance and report to management/ stakeholders.
- Ensure document/record controls and training management throughout the QMS.
- Ensure the proper execution of regulatory licenses change management.
- Maintain and manage quality agreements with internal and external parties.
- Respond to internal and external quality audits.
- Engage projects/tasks related to the transition and implementation of the internal quality management system.
- Ensure quality assurance complaint handling manage nonconforming products implement corrective and preventive actions recalls reporting defects to MAH (e.g. Philips Japan) and coordinate with them etc.
要件必須/Requirements (Mandatory)
- 医療機器業界において5年以上の経験を有しそのうち最低3年は品質部門での経験を有する方
- 医薬品医療機器等法ISO13485及び他関連する規制要件の知識を有する方
- 医療機器の品質マネジメントシステムのプロセスの構築と運用の経験を有する方
- 語学力 日本語及び英語力海外法人とコミュニケーション可能なビジネスレベル
- > 5 years of experience in the medical devices industry of which with a minimum of 3 years within quality field such as QA/QMS.
- Knowledge of the PMD Act ISO 13485 and other applicable regulatory requirements.
- Experience in establishing and operating quality management systems for medical devices
- Language: Japanese (Native level) English (Business Level)
尚可/Requirements (Preferred)
- AED/除細動器やその他の救急医療製品について十分な理解を示している方
- 医療機器ライセンスの取得とその後の維持管理の経験を有する方
- 事業拡大の進捗に応じて品質部門の最適な組織体制を設計管理できる方
- A thorough understanding of AEDs defibrillators and other emergency care medical devices
- Experience in obtaining medical devices licenses for a newly established legal entity and maintaining it thereafter.
- Ability to design and manage the optimal organizational structure for the quality department in accordance with business expansion progress.
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
