Philips Country Quality Manager 

Japan, Chiyoda 

609712615

品質保証部マネジャ/ Quality Assurance Manager

【背景】/【Back Ground】

【サマリー】/【Job Summary】

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.