Coord, Quality System

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

宮崎工場における品質システム業務の一部(製品リリース、文書管理、変更管理、NCR/CAPA、TSC品質運用、バリデーション管理、最終製品テスト、年次製品レビュー、内部/外部監査、マネジメントレビューなど)を実行します。

品質オペレーショングループと連携した校正管理、文書管理をサポートします。

• 手順とコンプライアンス要件に従って、彼女が担当するタスクを正確に実行します。

• テストまたはドキュメントの記録を確認し、適切に維持します。

• 機器や試験機器を正しく操作し、データを作成します。

• タスクレポートのデータを入力および編集します。

• EMSおよび改善活動を実施します。

Execute some of the Quality System tasks in Miyazaki Plant (Product release, Document control, Change control, NCR/CAPA, TSC quality operation, Validation control, Final product test, Annual product review, Internal/external audit, Management review, and others).

Support Calibration control, Document management in cooperation with the Quality Operation Group.

• Execute accurately the tasks of which she takes charge, following the procedures and compliance requirements.

• Review test or document records, and maintain appropriately.

• Operate the equipment and test instruments correctly, and create data.

• Input and edit data for task reports.

• Conduct EMS and Kaizen activities.

＜資格・学歴・経験＞

• 医療製品の製造と品質システムに関する基本的な知識 - GMP、QMS、製品、製造プロセス、および試験機器。

• コンピュータースキル(Excel、Wordなど)

＜ Qualifications / Education / Experiences ＞

• Basic knowledge about medical product manufacturing and quality systems - GMP, QMS, Products, Manufacturing process and Test instruments.

• Computer skill (Excel, Word, and others)

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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