Quality Engineer I at Medtronic-Switzerland

Tokyo, Tokyo, Japan -

Full Time

Start Date

Immediate

Expiry Date

15 Apr, 26

Salary

0.0

Posted On

15 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Complaint Analysis, Data Extraction, Microscope Operation, Communication Skills, Teamwork, Non-Destructive Testing, Failure Analysis, English Proficiency, Windows Office Skills, Attention to Detail, Medical Device Handling, Problem Solving, Technical Writing, Analytical Skills, Adaptability

Industry

Medical Equipment Manufacturing

Description

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＞ Complaint Returned Products Engineer（苦情分析担当 QA＠Tokyo）＜勤務地＞東京都大田区平和島TSS ＜部門について＞ Complaint Analysisは、QA（品質部門）に属しており、Center-ledというグローバルのQA部門に所属しつつ、日本のQA部門ともドットでつながっています。主な業務は、日本のMedtronic（ソファモアダネック、Covidien含む）すべての医療機器のうち、市販後に市場から提供された苦情・不具合品に関連する検査業務で、平和島にあるラボ（検査室）で実施しています。最終的な現品調査は海外製造元で行われることから、日本での検査は、登録された苦情情報と返却された苦情現品の状態の照合や、外観検査・非破壊試験・ログなどのデータ抽出です。これらの作業後、海外製造元へ輸出し、最終的な調査結果を確認しています。ただし、一部製品においては、海外製造元で実施する現品調査を日本で実施しており、この場合は、破壊試験（Failure Analysis）まで行います。日本では各種規制などの観点から、日本の苦情品のみを扱っていますが、同じ組織に属する別のチームはUSのイリノイ州にあり、ここではグローバルレベルでの現品検査を実施しています。日本のComplaint Analysisも、グローバルチームの所属として、今後、Failure Analysisを拡大していくにあたり、１名の増員が決定いたしました。＜業務内容＞市販後に苦情が発生し、返却された現品に対する検査および検査に関連する事務業務を実施いただきます。使用済の医療機器のため、現品には血液や組織片、体液などの付着があります。汚染対策はされていますが、これらの製品の取り扱いに抵抗ないことが前提となります。（感染症患者に使用した製品の返却は厳禁となっています。）担当製品の苦情情報の確認検査（外観撮影、非破壊試験、データ抽出）製品分析（破壊試験）海外製造元との情報共有（英語でのシステム入力、メール対応、文章読解など含む）営業担当者などとのコミュニケーション調査結果および結果に関連する文書作成＜Must Haves＞ Job Experience 実務経験２年以上品質・製造・検査・修理などの経験尚可業務でのWindows（Office）使用経験 Skill / Knowledge 英語力（目安としてTOEIC600点以上/英文読解・英文作成） OAスキル（Win 中級以上） Competency 協調性、コミュニケーションスキル顕微鏡操作や、機器の動作確認・分解操作に抵抗がないこと（細かい作業が得意な方）電子部品や回路を含め、医療機器の取り扱いについて習熟しようという意欲のある方 Education 学士以上（学部・学科は問わない）＜Nice to Haves＞ Job Experience 医療業界や品質、製造、検査、修理部門での経験ネットワークセキュリティ関連業務の経験 Skill / Knowledge 情報処理やネットワーク関係の知識電子工学、臨床工学などの知識英会話スキル（英語での会議に参加できるスキル） Competency PCなど機器類の組み立てや分解が得意な方客観的な思考や、慎重な対応が出来る方＜Working Style＞担当する製品の進捗にあわせて、ご自身で出勤もしくは在宅ワーク/フレックスワークを調整していただきますが、出社頻度は週３～５日程度です（業務進捗状況による）。各製品に対し、専任担当は設定しますが、チーム内で専任以外でも対応ができるように業務を共有しています。そのため、専任担当の出勤が難しい場合や夏季休暇取得時など、チーム内でお互いにサポートできる体制づくりに努めています。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 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. 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

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Responsibilities

The role involves inspecting returned medical devices related to complaints and conducting related administrative tasks. This includes verifying complaint information, performing inspections, and communicating findings with overseas manufacturers.