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:ニューロサイエンスポートフォリオ
脳を含む頭頚部、痛み、脊椎などの領域において、開創から術中、閉創までの多岐にわたる手術支援機器、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
プロダクト・クオリティー部門の一員として、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。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。
- 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。
Main Responsibilities
"A Day in the Life"
1.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。
2.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。
3. 修理業、販売業、貸与業からの問合せに対する回答・指示の作成
Must Haves
Knowledge/Education:大卒以上
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)
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/日本語ネイティブレベル
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)、PowerAutomateの作成経験
その他:品川オフィス(出社頻度 週1度程度)
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.
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
-
Tokyo Medtronic Full time￥5,000,000 - ￥8,000,000 per yearAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. · p苦情担当スペシャリスト · tough punishment specialist · safety management department member performing following duties: kakujou shori: customer complai ...
-
Tokyo Medtronic Full time￥4,000,000 - ￥8,000,000 per yearAt 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. · Internal, external audits · Trend a ...
-
Tokyo Alcon ￥2,500,000 - ￥5,000,000 per year日本の医薬品・医療機器法に基づくGVP省令関係業務、安全管理情報のグローバルからの要求事項に対する業務、安全管理情報の収集・評価を通し、アルコン社の医薬品・医療機器・医薬部外品の適正使用を通して安全性を確保する。 · ...
-
Tokyo Alcon Research ￥100,000 - ￥200,000 per yearSr. Specialist,Safety Vigilance/ 斻20209-20231020. · GVP ordinance-related work based on Japan's Pharmaceutical Law,&global requirements for handling safety management information. ...
-
Tokyo, Tokyo Stryker ￥12,000,000 - ￥18,000,000 per yearDevelops and implements processes involved with maintaining annual licenses, registrations, and listings, reviews and approves advertising and promotion to ensure regulatory compliance, assures post-market regulatory requirements are met, submits notifiable changes and supplement ...
-
Chiyoda Bristol Myers Squibb Full timeChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest br ...
-
Tokyo Dexcom Full time￥2,000,000 - ￥2,500,000 per yearThe customer advocacy specialist will establish maintain improve dex com japan good vigilance practice process execute lead safety activities japan safety sr safety specialist. · ...
-
Tokyo Dexcom ￥5,000,000 - ￥8,500,000 per yearDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). We are driven by thousands of ambitious people worldwide who are willing to fight like warriors to earn the trust of our customers. · ...
-
Tokyo ZOLL Medical Corporation ￥6,000,000 - ￥9,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
Chuo-ku, Tokyo Johnson & Johnson MedTech ￥600,000 - ￥1,200,000 per yearThe Safety Management Specialist will perform work under general management supervision to ensure compliance with regulations and quality metrics. · ...
-
Chuo-ku, Tokyo, Japan Johnson & Johnson Innovative Medicine Full time￥3,000,000 - ￥6,500,000 per yearIn compliance with MHLW ordinance 169 Quality Management System, MHLW ordinance 135 Good Vigilance Practice, FDA , European MDD/MDR & other International Regulations,the position will perform work under general management supervision. · The Safety Management Specialist will ensur ...
-
Tokyo Dexcom ￥60,000 - ￥120,000 per yearThe Company Dexcom Corporation is a pioneer in continuous glucose monitoring (CGM). We are driven by thousands of ambitious people worldwide who listen serve with integrity think big and depend on each other. · ...
-
Regulatory Affairs
2週間前
Tokyo, Japan ZOLL Medical $90,000 - $120,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...
-
Regulatory Affairs
1週間前
Tokyo ZOLL Medical Corporation ￥5,500,000 - ￥10,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
Sagamihara Johnson & Johnson MedTech ￥90,000 - ￥120,000 per yearIn compliance with MHLW ordinance 169 Quality Management System, MHLW ordinance 135 Good Vigilance Practice, FDA European MDD/MDR & other International Regulations, · ...
