Jobs list of Medical Device & Quality Assurance / Quality Control
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Job number: JN -082024-171310 Posted: 2024-09-11
QAマネージャー
医療機器業界での品質保証もしくは薬事経験（目安3年以上）をお持ちの方必見です。8 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are a global medical devices and pharmaceutical company providing healthcare-related products. We offer a wide range of products including pharmaceuticals, medical devices, and consumer goods to support healthy living. Particularly, through investments in medical technology and research and development, we provide advanced medical solutions, enhancing the quality and efficiency of healthcare. Additionally, we contribute to raising awareness of health in society through education and outreach activities, aiming for a better future.
- Responsibilities
- 新製品導入や製品設計、製造プロセスなどのGo/No-Goの最終承認
品質関連文書の発効承認（他組織との品質契約書、品質関連の自社規定諸・手順書、資材規格書、製品規格書、製品標準書など）
製品やシステムに関する新規PJTに対する品質観点からのガイド（国内外他社との交渉を含む）
顧客クレームのプロセス管理（KPI管理）、個別クレームに関する対応・措置検討決定、個別顧客への対応（顧客訪問など）
製品の出荷停止、製品回収、その他の市場措置対応の決定に関する関連部門との調整および措置決定・措置実施完了までのリード
所轄省官庁、第三者認証機関との調整と対応決定・対応実施完了までの管理
各署との交渉や調整
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -082024-170838 Posted: 2024-09-11
【東京】医療用内視鏡の安全管理（スペシャリスト）
医療機器業界における安全管理業務経験者必見です!8 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a global manufacturer specializing in optical technology and healthcare, offering a wide range of products and services. Our main business areas include precision optical instruments, medical devices, and consumer products. We possess advanced technical capabilities, particularly in eyewear lenses, contact lenses, and endoscopes, and we are dedicated to developing innovative products. Additionally, we utilize cutting-edge technology in fields such as semiconductor manufacturing equipment and optical components to enhance our competitiveness in the global market. Through advanced research and development and rigorous quality control, we meet customer needs and deliver high reliability and performance.
- Responsibilities
- 苦情に関する、不具合報告要否判断
不具合報告書作成およびレビュー
回収（改修）要否判断
回収（改修）報告書作成およびレビュー
行政とのやり取りおよび必要な対応の実施
研究報告書作成およびレビュー
外国行政動向調査実施
外国措置報告書作成およびレビュー
PSUR（安全性定期報告書）作成およびレビュー
市販後業務に関する社内手順書作成およびレビュー
添付文書改訂
文献調査
【変更の範囲：会社の定める業務】
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -082024-170775 Posted: 2024-09-11
GMP業務・マスターファイル管理業務
医薬品承認申請経験をお持ちの方必見です。8.4 - 10.9 million yen Kansai Medical Device Quality Assurance / Quality Control
- Company overview
- We are a company that offers a diverse range of products and services, including chemicals, plastics, electronic components, machinery and equipment, and food products. With a long history and based on strong relationships with our customers and partners, we are expanding our business both domestically and internationally. We also focus on technological development and environmental initiatives, actively contributing to the realization of a sustainable society. In a wide range of industrial fields, we are continuously growing to meet the diverse needs of our customers by leveraging our expertise and flexible response capabilities.
- Responsibilities
- マスターファイル登録、当局審査、維持管理業務
輸入医薬品の規格及び試験方法の設定業務
GMP適合性調査対応業務
輸入医薬品（原薬）の製造（表示・保管）・試験に関するGMP業務
Go Ozawa
Medical Device