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** **JOB TITLE:** **Quality Systems Specialist** **DEPARTMENT: JAPAN QARA** **REPORTING TO: QA MANAGER** ************************************************************************************************** **Main Mission of Job** **“** **Careers that Change Lives** **”** **担当製品：** **循環器内科、心臓血管外科等の心臓周辺に関連するデバイス** **安全管理部門の一員として、以下の業務を行う。** **-** **苦情処理：顧客から挙げられた製品に対する苦情報告内容を確認し、必要に応じて追加情報の収集を行う。** **-** **行政報告：国内外から受理した苦情内容を評価し、必要に応じて** **PMDA** **に報告を行う。** **-** **添付文書管理：海外製造元が作成する** **IFU** **の改訂、または** **RA** **が行う軽微変更や一部変更に合わせて添付文書の記載内容を改訂する。** **-** **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。** **-** **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。** 　　　　　　　　 **Main Responsibilities** **“** **A Day in the Life** **”** **苦情処理と** **PMDA** **報告書の作成** **医療機関・代理店から上がってきた苦情報告を確認し、必要に応じて追加情報の収集を行う。** **また、国内において** **PMDA** **報告要否の判定を実施し、報告要となった症例については** **PMDA** **に行政報告を行う。** **２．添付文書管理** 　　　 **IFU** **の改訂内容を確認し、必要に応じて添付文書改訂を行う。** 　　　 **RA** **が実施する軽微変更や一部変更で生じた変更について、** **PMDA** **に事前相談を行い、添付文書改訂を行う。** **３．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。** **４．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。** 　　 **Must Haves** **Knowledge/Education** **：大卒以上** 　 **Job Experience** **：** **医療業界での品質保証又は品質管理経験** **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** **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）** **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 (http://www.medtronic.com) 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. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com