At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

JOB TITLE: Quality Systems Specialist

DEPARTMENT:JAPAN QARA

REPORTING TO: QA MANAGER

**********************************************************************************************

Main Mission of Job

Careers that Change Lives

担当製品ニューロサイエンスポートフォリオ

脳を含む頭頚部痛み脊椎などの領域において開創から術中閉創までの多岐にわたる手術支援機器疾患症状を緩和する治療法および急性期治療に関連するデバイス

プロダクトクオリティー部門の一員として以下の業務を行う

-監査対応等内部監査外部機関からの監査対応やサポートをする両方ある

-トレンド分析製品群ごとに苦情報告のトレンドを解析する

- 顧客対応分析報告書の発行

- 回収対応製品に不具合が生じた際に回収事案となった場合は社内の回収プロセスに則って関係者社内製造元と連携し円滑に回収作業を実施するまた規制当局への報告をする

- 社内の製造業修理業販売業貸与業と連し業務を行う

Main Responsibilities

A Day in the Life

1監査対応

内部外部の監査に向けて事前準備を行い監査当日の対応を行う

2回収作業

回収事案が生じた場合に安全性有効性について評価する

製造元の回収計画に準じて社内向けの回収計画を策定し関係者と連携して作業を行う

3.修理業販売業貸与業からの問合せに対する回答指示の作成

Must Haves

Knowledge/Education大卒以上

Job Experience薬機法に基づく品質保証又は品質管理経験医療機器業界が望ましい

Competencies/Language Skillsコミュニケーション/交渉力プレゼンテーションスキル実務での英語読解

ライティング経験/日本語ネイティブレベル

Computer Skills: PowerPoint/Word/Excel

Nice to Have

• 薬機法の知識QMS省令ISO13485 等の規格の知識

Skills/Competency: プロジェクトマネージスキル

Computer Skills: エクセルスキル中級トレンド分析集計業務の確認などPowerAutomateの作成経験

その他品川オフィス出社頻度 週１度程度

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here