Coord, Quality System
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
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 dont 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/CAPATSC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(ExcelWord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
Recruitment Fraud Notice
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Key Skills
- Computer Science
- Business Process
- Active Directory
- ISO
- Linux
- Project Management
- Sharepoint
- ERP
- QA
- User Training
- System upgrade
- System Administration
- SDLC
- Setup
- UNIX
About Company
The user-friendly Amia APD system, powered by Sharesource Connectivity Platform, is designed to simplify home peritoneal dialysis for both clinicians and patients.
