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 ： [Senior] QUALITY SYSTEMSL SPECIALIST
DEPARTMENT ： QMS / QUALITY MANAGEMENT
REPORTING TO ： SENIOR QUALITY SYSTEMS MANAGER
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MAIN PURPOSE OF JOB:
- Improve and maintain the effectiveness and efficiency of quality management systems and conformance to regulatory requirements of medical devices while considering the needs of customers.
顧客ニーズを考慮しながら、医療機器の規制要求事項への適合及び品質マネジメントシステムの有効性と効率性を維持する
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MAIN JOB DUTIES / RESPONSIBILITIES:
- Establishment and maintenance of quality management systems focusing on QMS governance and management of QMS requirements
品質マネジメントシステムの構築および維持管理業務: FocusエリアはQMSのガバナンス（Management Review等）とQMSに関する要求事項の管理
- Management of projects for improving QMS
品質マネジメントシステムの改善プロジェクトの推進
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Careers That Change Lives
Quality Management System is the function that establishes and maintains the processes affecting product quality and patient safety based on reguratory requirements such as Japan PMD Act., MHLW Ordinance #169 (QMS Ordinance), ISO13485 and so on. The function is the basis of the business of medical devices – business enabler. The position will be responsible for:
- CAPA (corrective actions and preventive actions): The provcess to take actions to eliminate the causes of nonconformities which are identifiled through the use of various processes such as audits, post-market surveillance, analysis of the data and so on in order to prevent recurrence.
- Internal Audit: Plan and conduct internal audit to determine whether the quality management system conforms to the regulatory requirements and the procedures and is implemented effectively.
- Business licence management: Gain and renew business licenses which are required to do the business of medical devices in Japan
品質マネジメントシステム（QMS）は、薬機法やISO13485に基づいて、製品品質と患者安全に係わるプロセスの構築と維持に責任を持つ部署です。ビジネスの基本であり、ビジネスを可能にする機能と言えます。
担当する役割は下記に責任を持ちます：
- CAPA（是正予防措置）：監査、市販後監視、データ分析等のプロセスを通して特定された不適合の原因を再発を予防するために除去するプログラムを運営します。
- 内部監査：品質マネジメントシステムの規制要求や手順への適合や効果的に運用されているかについて、内部監査を計画し実行します。
- 業態管理：医療機器のビジネスを国内で行うために必要な業許可を取得し、更新します。
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's
mission globally.
以下の職務を担当するほか、他の任務が割り当てられることもある
• 品質プログラム、システム、プロセス、手順を監督し、ポリシーへの準拠およびサービスのパフォーマンスと品質が確立された標準や規制機関のガイドラインに準拠することを確認する。
• ポリシー、条例、政府規制、規制当局によるガイドラインの解釈に専門知識とガイダンスを提供し、正しく準拠することを確認する。
• 運営事業体に直接働きかけ、プロセス分析監督を継続的に提供し、要件の実施を徹底し、ガイドラインを満たす。
• 監査や検査の準備を率先し、監査や検査の結果を解決し、監査のすべての段階で監査グループや検査者と連絡を取る。
• 政府による操作や訴訟をサポートするための法務質問を調整する。
• 品質保証プログラムとポリシーが維持され、定期的に改訂されていることを確認する。
• 世界各国で統一された標準を促進し、ベストプラクティス共有を可能にし、会社のミッション達成をグローバルに達成できるようにする。
Required Knowledge and Experience:
Requires mastery of a specialty area and full knowledge of industry practices, typically
obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8
C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
専門領域に精通し、通常、高等教育と経験から得た業界慣行に関する詳細知識が必要になります。. プロジェクト管理についての幅広い知識を持ち合わせている場合があります。四年制大学の学位と7年以上の先行経験、もしくは修士号または学士号より上のその他の高等学位と5年以上の先行経験が必要です。
Nice to Have（あれば望ましいもの）
- Practical knowledge on executions of quality-reated processes and safety controls
- Fluent in English – Presentation skills in English and communications skills in the meeting are preferred.
品質関連また安全管理業務の実務経験があることが望ましい。
英語でのプレゼンテーション、会議での英語でのコミュニケーションなどの英語が流暢であることが望ましい。
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
