At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world. About the Role #BetterDaysStartNow 職務内容＜ポジション名＞ Quality Systems Specialist ＜勤務地＞品川本社＜当社について＞ミニメドジャパン合同会社は、糖尿病患者さん及び、その人を大切に思う人の幸せのために、革新的で魅力のある製品・サービス・情報を提供し、患者さん一人ひとりに合わせたソリューションを導くことで、QOLを改善し、健康寿命を延伸させるというビジョンに基づき、日々業務を行っています。現在取り扱う製品のインスリンを皮下に持続注入するインスリンポンプ(CSII)、血糖変動の傾向を評価するリアルタイムCGM、更にはCGMと連動し自動でインスリンを増減する注入方法のAID療法を用いて糖尿病治療のパイオニアとして日本及び世界中の患者さんのQOL向上にも貢献しています。＜業務内容＞品質保証業務及び安全管理業務以下の業務の中で、経験等に応じてご担当いただきます。・回収/改修、情報提供の実施及び行政への対応・QMS維持運用・改善(品質マニュアル・手順書・製品標準書の整備) ・内部監査・外部監査のサポート、承認に伴うPMDAによるQMS適合性調査への対応・製品の法定表示・製品ラベル・パッケージングの仕様策定・製造元との調整・製品出荷判定、医療機器プログラム出荷判定、附帯サービス・苦情・外国措置報告プロセスについての製造元との調整、PMDAへの不具合報告等・不適合処置・CAPA/SCAR対応・海外を含む関連会社、他部門や他社などのステークホルダーとの協力体制構築と共同での業務推進・顧客報告書（海外製造元による調査報告書）の作成およびレビュー＜必須のスキル＞・MS Officeのアプリケーションが使用できること・医療機器業界における品質保証又は安全管理業務に関する最低3年の職務経験・医薬品医療機器等法に関する知識、QMS、GVPの知識・英語の読み書きができること＜学歴＞・学士以上（学部・学科は問わない）＜あれば尚可＞・英語・日本語の話し言葉・書き言葉の両方に優れた能力・社内外のステークホルダーと円滑なコミュニケーションが取れる方＜働き方＞・基本的にはリモート勤務、必要に応じて出社 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 MiniMed offers a competitive salary and flexible benefits package At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. About MiniMed We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it. MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. With a heritage rooted in technology, empathy, and a relentless pursuit of innovation, we’re focused on one thing: making every day a better day for people with diabetes. From our intelligent dosing systems that stay one step ahead to our always-on support when it’s needed most, we’re committed to building a connected system of care that works together and fits into everyday life, so people with diabetes can move through the day with fewer interruptions. Fewer second guesses. And more freedom to live in the moment. We’re here to make better days possible for people with diabetes. Joyful, messy, fully lived days. Days where things feel lighter, easier. For more than four decades, we’ve been driven by this mission, delivering groundbreaking advancements in technology to help people live more fully, freely, and with greater confidence. At MiniMed, diabetes care is personal for us. Many of our employees have a connection to diabetes, whether they're living with it themselves or through family members and friends, and we all show up each day to help make the lives of our coworkers and loved ones easier. Our people-first priority. At MiniMed, we put our customers at the forefront of all we do, and that focus extends to our team as well. We're dedicated to creating a culture of belonging and providing our people with all the career-building resources you might need. Our life-transforming technologies. No matter what your role at our company, you're making a difference in the lives of people with diabetes. Our innovative inventions improve their day-to-day by helping lift the mental load and allowing diabetes to fade into the background, empowering them to live life on their own terms. Our focus on the future. We're chasing the dream of a world where people with diabetes can be free of that never-ending battle of balancing blood sugar. A world where better days are the norm, not the exception. Fresh faces and new viewpoints will help create our cutting-edge solutions and define the next generation of breakthroughs in care, so that a better day can start today. It is the policy of MiniMed 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, MiniMed 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. For updates on job applications, please go to the candidate login page and sign in to check your application status.

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