■POSITION SUMMARY■
In the Regulatory Affairs and Quality Assurance Department, the main responsibility is quality control and quality assurance activities related to the manufacturing and marketing of medical devices, in the role of Domestic Quality Assurance Manager.
In the future, there is a possibility that it will take on the role of General Manufacturing and Distribution Manager.
薬事品質保証部にて、医療機器の製造販売業および製造業に関わる品質管理・品質保証業務を、国内品質業務運営責任者としてご担当いただきます。将来的には、総括製造販売責任者の役割をお任せする可能性もあります。

■KEY RESPONSIBILITIES■
Quality Assurance
Serve as the Quality Responsible Person for medical device manufacturing and distribution operations (Domestic Quality Assurance Manager, related fields, or equivalent experience).
•Evaluate the results of manufacturing & quality controls appropriately and decide market release of the products..
•Evaluate and verify that both domestic and foreign manufacturers perform manufacturing & quality controls appropriately.
•Evaluate and verify changes from manufacturers (domestic and foreign) based on change management procedures.
•Collect quality information and evaluate necessary measures and issue documentation-based quality notices to relevant organizations.
•Provide instructions regarding notifications prior to resale or leasing of used devices, and guide repair agents on required notifications before repair.
•For the cases requiring recalls, to coordinate the recall with local regulatory agency to initiate and close them..

Quality Management System (QMS)
•Implement and maintain the requirements of the ISO 13485, and Quality Management System.
•Conduct internal audits to ensure compliance with the Quality Management System and regulatory requirements.

Quality Control Duties
•Manage domestic manufacturing processes and perform maintenance and improvement of processes.
•Work with 3PL (Third-Party Logistics) and conduct supplier audits.

Other Duties
•Establish, maintain, and implement communication initiatives to enhance awareness of QMS across the business and promote the resolution of quality-related issues.
•Build strong relationships with related departments (SCM, Safety Management, Marketing, and Sales) to improve processes and contribute to overall company quality improvement.

品質保証業務
医療機器製造販業の品質責任者業務（国内品質業務運営責任者としての業務経験、またはそれに関連する業務経験・同等の経験をお持ちの方）QAマネージャーと連携し、QAスタッフをリードしながら業務を行って頂きます。
•製品の市場への出荷の判定
•製造所（国内、海外）の定期的な確認
•変更管理、製造業者における変更の評価、変更の妥当性の確認
•品質不良情報等の収集と必要な措置の検討、関係機関への品質情報等の文書による通知
•中古販売／貸与前の通知に関する指示及び修理業者からの修理前の通知に関する指示
•回収発生時に当局対応、回収作業を遅滞なく実行

品質マネジメントシステム（QMS）関連業務
ISO13485:2016 要求事項の順守と維持管理、認証機関対応
内部監査、文書管理等の品質マネジメントシステムの運用

品質管理業務
国内の表示包装保管プロセスを確実にし、プロセスの維持管理及び改善
3PLとの連携及びサプライヤー監査の実施

その他
ビジネス全体の QMS に関する意識を高め、品質に係わる問題の改善を促進するためのコミュニケーションを 確立、維持、実施する。
関連する他部署（安全管理、マーケティング、営業）と良好な関係を築き、プロセスの改善を行い、会社全体の質向上に努める