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.
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
9001730
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. 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.
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
Required Experience:
IC
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