Quality Officer - Japan (国内品質業務運営責任者 – 日本 )
1 month ago
SCOPE:Based on the strategy of the U.S. headquarters, you will ensure that products manufactured and sold in Japan comply with the QMS Ordinance. Spec.....
SCOPE:
Based on the strategy of the U.S. headquarters, you will ensure that products manufactured and sold in Japan comply with the QMS Ordinance. Specifically, you will bear direct responsibility for maintaining the quality management system in Japan, under Sirtex Global Quality Management System and, in cooperation with overseas manufacturing sites, ensure that the quality management systems at those sites meet the requirements of the QMS Ordinance.
米国本社のストラテジーを踏まえて、日本において製造販売する製品がQMS省令に適合していることを確実にして頂きます。具体的には、グローバル品質マネジメントシステムの下で、日本における品質マネジメントシステムの維持管理に直接的な責任を持って頂くと共に、海外製造所と協力して、海外製造所における品質マネジメントシステムがQMS省令の要求事項を満たしていることを確実にして頂きます。
Candidates must reside in Japan
PRIMARY RESPONSIBILITIES:
- Establishment, Operation, and Maintenance of Quality Management Systems in Japan
- Management Review
- Internal Audit
- Document and Record Control
- Training and Education
- Supplier Management (including management of agreements under Article 72 of the QMS Ordinance)
- Risk Management
- Complaint Handling
- Nonconforming Product Control
- CAPA
- FCA
- External Audit Support
- Market Shipment Approval
日本における品質マネジメントシステム体制の構築・運用・維持
Ensuring Overseas Manufacturing Sites' QMS Compliance with QMS Ordinance
Training
Assessment
Improvement
Monitoring
海外製造所における品質マネジメントシステムのQMS省令への適合
Regulatory Labeling Management
法定表示管理
Regulatory Registration License Management (e.g. MAH License, Overseas Mfg. Site License, Domestic Selling License, etc)
業態管理(海外及び国内)
Other Quality Assurance Activities (Including Government/Industry Relations)
その他品質保証に関する業務(行政/業界対応含む)
Official account of Jobstore.