Sr. Specialist / Quality-QA and QMS

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.

Quality assurance related work for medical devices, pharmaceuticals, etc.

• Comply with laws and regulations, improve/maintain product quality, and realize the "Quality Policy."

医療機器及び医薬品等の品質保証関連業務

• 法規制及びコンプライアンスを遵守し、製品の品質を改善／維持し、「品質方針」を実現する。

Manage market quality information in accordance with relevant regulatory laws, such as the Pharmaceuticals and Medical Devices Act and QMS/GQP minutes.

(1) Create and maintain agreement books with manufacturers

(2) Create and maintain product standard books

(3) Change management, deviation processing, corrective and preventive measures, quality information response

(4) Obtain necessary information on product quality from domestic manufacturers

(5) Create required procedure manuals for QMS/GQP

2. With support as needed, work with manufacturers to investigate quality information on medical devices manufactured in Japan, and continuously improve and maintain product quality.

3. As the QSR (Quality System Representative) for CSV, evaluate CSV-related documents. In addition, provide appropriate advice on CSV implemented by related departments and ensure proper response.

1. 薬機法、QMS／GQP省令等、関連する法規制に則って、市場品質情報を取り扱う。職務を行うにあたり、主として下記を運用する。

(1)製造所との取り決め書の作成・維持管理

(2)製品標準書の作成・維持管理

(3)変更管理、逸脱処理、是正・予防措置、品質情報対応

(4)国内外製造所からの製品品質に関する必要情報の入手

(5)QMS／GQP上必要な手順書等の作成

2. 必要に応じてサポートを受けながら、国内外で製造する医療機器等について、製造所の担当者と連携して品質情報を調査し、継続的に製品品質を向上、維持管理する。

3．CSVのQSR(Quality System Representative)として、CSV関連文書を評価する。また、関連部門で実施するCSVに関しては、適切にアドバイスするとともに、確実な対応を促す。

主な職務内容　Key Responsibilities

1. Pharmaceuticals and Medical Devices Act, QMS/GQP Ministerial Ordinance, and other related laws and regulations

2. Able to communicate smoothly with site personnel in Japan and overseas.

3. English skills necessary to carry out work (ability to communicate via email, conference calls, and understand global SOPs)

4. PC skills: Microsoft Office

1. 薬機法、QMS／GQP省令等、関連する法規制

2. 国内外のサイトの担当者と円滑にコミュニケーションを図ることができる。

3. 業務を遂行する上で必要な英語力（メールでのコミュニケーション、電話会議でのコミュニケーション、グローバルのSOPが理解できる）

4. PCスキル　Microsoft Office

求められる経験・スキル・知識　Qualifications / Education / Experiences

• Experiences:

- Strong QA experience for 3 years+ in pharmaceuticals or medical device field.

• Ability/Skills:

- Knowledge of GQP/QMS ministerial ordinance and related laws with QMS/ISO13485 process.

- Ability to handle complex problems/projects by exercising independent decision making and

analytical thinking skills within generally defined practices and policies

- Flexible and adaptable with strong conflict management skills.

- Ability to work independently under pressure and prioritize multiple tasks

- Ability to lead and influence, and to support others within team

- Good organizational skills with people management

- Good written and verbal communication skills in Japanese and English

Competencies & Licenses (required qualifications and licenses)

• Pharmacist (Preferable)

• TOEIC 700 equivalent or higher

• Equivalent to MS Excel/Word Expert

• Knowledge of Power automate, Power apps, Power BI, etc. (preferable)

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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