MDR/Vigilance Specialist job opportunity at Medtronic plc.

Home Jobs In Japan Tag: Job MDR/Vigilance Specialist position at Medtronic plc


DateMore Than 30 Days Ago bot
Medtronic plc MDR/Vigilance Specialist
Experience: General
Pattern: full-time
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degreeGeneral
loacation Tokyo, Tokyo, Japan, Japan
loacation Tokyo, Tokyo, ..........Japan

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life ＜ポジション名＞ Quality Systems Specialist ( JAPAN QARA/ Product Quality ） ＜勤務地 ＞ 品川本社 ＜部門について＞ Product Qualityは2025年10月に品質・市販後安全管理組織が再編成されたことで発足した新しい部署です。品質の業務を通して、社内の他部署、海外製造元と連携する業務があり又、監査・行政対応など社外の関係者と関わる機会があります。 ＜業務内容＞ 担当製品：　ニューロサイエンスポートフォリオ（CST ET/ ENT/ NM/ NV） ​​​​​​​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 Product Quality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。 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。 ＜Must Haves＞ Job Experience 業務での手順書等、文書作成経験 Skill / Knowledge Language Skills：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 Competency コミュニケーション/交渉力、プレゼンテーションスキル Education 学士以上（学部・学科は問わない） ＜Nice to Haves＞ 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、入社時に経験が無い場合、入社後、積極的に習得することが求められる） Skill / Knowledge 薬機法の知識、QMS省令、ISO13485 等の規格の知識 英語でのオーラルコミュニケーション経験 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 Competency プロジェクトマネジメント経験 ＜Working Style＞ 品川オフィス（出社頻度 週１度程度） ベネフィット メドトロニックでは、会社の成功と社員の成長は共にあるべきであると考えています。社員一人ひとりの経済的、身体的、精神的な幸せを高められるような、充実した福利厚生と報酬プログラムを用意しています。 年間最大36万円の育児費用補助 家族に介護が必要になった場合や養子縁組の際などに6週間取得できる休暇制度 ベビーシッターや保育園のマッチングサービス メンタープログラムやe-learningなどを含むキャリア開発 女性の活躍を支援する社内キャリアネットワーク 自社株購入制度　 etc. その他 ＜諸手当＞ 通勤手当、勤務時間外手当、休日勤務手当　etc. ＜休日＞ 土曜日、日曜日、祝祭日　etc. ＜休暇＞ 年次有給休暇、公傷病休暇、生理休暇、産前産後休暇　etc. ＜勤務時間＞ 9：00～17：30　 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.   This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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 95,000+ 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    

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