Jobs list of Medical Device & Quality Assurance / Quality Control
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Job number: JN -082024-172097 Posted: 2025-01-09
【本社】品質保証マネージャー（医療機器の3PL物流倉庫）
医療機器企業で品質管理業務経験者必見です!6 - 8 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are a global logistics company group providing a wide range of logistics services including sea freight, air freight, customs clearance, and warehousing. Our expertise lies particularly in marine logistics, where we ensure efficient and economical management of marine parts through dedicated centers and warehouses connected to our extensive network of offices worldwide. Additionally, our project division supports the acceleration of turnaround times for ship repairs, maintenance, or conversions and facilitates just-in-time delivery of parts for new builds.
- Responsibilities
- 【変更の範囲：会社の定める業務】
横浜倉庫(医療機器・体外診断用医薬品。ライセンス：医療機器製造業・販売業、医薬品製造業・医療機器販売業):
顧客側のQAと品質に関するコミュニケーション
手順書の変更管理
内部監査の実施／結果報告／フォロー
是正処置報告書作成
定期的な品質管理の社内研修
現場折衝・顧客対応アドバイス
市川倉庫（医療機器。ライセンス：医療機器製造業、高度医療機器等販売業貸与業）:
既存所有の製造業・販売業のQMS文書管理及び市場に合わせた更新/変更
定期的な社内研修
内部監査の実施／結果報告／フォロー
顧客又はコンサル会社とのコQMS・ライセンス／業態に関するコミュニケーション
現場折衝・顧客対応へのアドバイス※部署立ち上げのため、Individual Contributorとして稼働していただきます。
RFQ（Request for Quotation、ヘルスケア領域の新規ビジネス案件への営業サポート）:
顧客の要件に従い、必要なライセンス／業態、人員/資格、予算、タイムラインの作成及び/提案
顧客の要件に従い、該当する市場の調査
顧客への品質に関するプレゼン資料の作成、顧客への説明
当社内のQC／QAの仕組みの理解と、顧客への説明
Go Ozawa
Industrial & Life Science -
Job number: JN -112024-180614 Posted: 2024-12-23
Quality Manager
ライフサイエンス領域大手10 - 13 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a leading biotechnology provider dedicated to advancing scientific and medical research. Based in Tokyo, Japan, it plays a vital role in enhancing research across fields such as molecular medicine and forensic science.
Globally, our client operates in approximately 160 countries. The Japan branch is a key part of this network, offering cutting-edge products and services essential to life sciences labs worldwide. Its innovative instrument systems and comprehensive range of reagents support significant advancements in biotechnology. - Responsibilities
- 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る品質保証業務
業務内容：
品質保証担当者と連携し、Quality Management System (QMS)の運営、維持管理の実施QMS関連文書の新規作成及び改訂
関係部門との協働による新製品の市場上市計画の策定と実行
製造販売開始および変更時におけるリスク分析の実施
内部監査及び自己点検、供給業者の評価の実施
国内製造委託業者の管理
製造販売後安全管理に関する業務の対応（情報収集、当局報告、記録書作成保管等）
薬事関連教育訓練の実施及び管理
年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等
QMS適合性調査対応の実施
製品の製造販売承認／認証申請時のQMS適合性調査申請資料の作成
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-34137 Posted: 2024-09-18
PV Manager
Pharma業界の方歓迎10 - 13 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are the Japanese subsidiary of a leading U.S. company in the pharmaceutical and healthcare industry, offering a wide range of products. We provide high-quality and high-performance products and services that cover a broad spectrum from diagnostics to treatment, including diagnostic drugs and devices, pharmaceuticals, hospital products, and nutritional supplements. We have earned high praise for our offerings. Naturally, there is also interdepartmental mobility and information sharing, which helps us maintain our overwhelming position as a comprehensive healthcare manufacturer.
- Responsibilities
- Manage the collection, processing and assessment of safety related information as it relates to the company's Nutrition products in compliance with applicable regulatory requirements and guidelines, as well as division and corporate level policies and procedures; Ensure the pharmacovigilance (PV) system for the company's Nutrition products registered as drugs in Japan is in place and is compliant with regulatory standards; Maintain the PV IT system used for adverse event reporting. The manager is considered a subject matter expert in the area of pharmacovigilance.
Main responsibilities:
Manage the Japan PV team (through guidance and supervision) in the collection, review, and assessment of adverse event reports/safety related information
Ensure submission of reportable adverse events to the health authority in accordance with requirements and timeframes outlined in local regulations
Develop and maintain local standard operating procedures that are aligned with corporate/division level policies and procedures and follow local regulations
Develop and provide PV training for new/junior team members and local affiliate staff
Serve as the point of contact for all local PV activities, inquiries and issues, including responding to inquiries from the health authority
Prepare and submit periodic reports to the health authority in compliance with local regulations
Conduct internal inspections of the PV system as required by local regulations
Serve as the PV lead during internal audits and external inspections; prepare and execute CAPAs for any PV related findings
Participate in the review of promotional materials
Act as the safety database administrator, including coordinating maintenance and upgrades of the PV IT system
Manage vendor and process associated with searching of scientific literature for safety related information
Participate/collaborate with the Medical Safety & Surveillance team on global safety/pharmacovigilance related initiatives and goals
Functions independently as a decision-maker within specified parameters and decisions could potentially have financial ramifications or impact brand reputation, regulatory compliance, or patient and product safety.
Individual is recognized as an internal subject matter expert and resource with responsibilities that require high level critical thinking and analytic abilities.
Leads cross-functional projects related to the area of expertise with a high level of visibility across the local affiliate site.
Responsible for ensuring compliance with local regulatory requirements related to pharmacovigilance for Japan’s drug products.
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-22568 Posted: 2024-09-11
内視鏡品質保証業務
日系大手医療機器メーカー 内視鏡品質保証業務6 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are a major corporation based in Japan, offering a wide range of products and services. Beyond just photographic film and cameras, we also specialize in medical equipment, chemicals, optical devices, and more. Our focus is on the quality, innovation, and sustainability of our products, providing value to customers worldwide. Additionally, we prioritize research and development, contributing to advancements in science and technology.
- Responsibilities
- 内視鏡システム製品及び関連製品の品質保証業務、および、品質管理システム(QMS)スペシャリスト内視鏡製品の製造販売業者としての品質保証業務(国内、海外)
内視鏡開発のQMSの管理運営、及び、監査・査察対応業務(MDSAP、MDR/IVDR、FDA査察、適合性調査他)
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-4098 Posted: 2024-09-11
【幡ヶ谷】品質保証
大手日系企業の品質担当5.5 - 7.5 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
- Responsibilities
- 品質マネジメントシステム改善
各国規制への適合化に関する業務
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-149604 Posted: 2024-09-11
Quality Control | 品質管理
高クラス医療機器の品質管理・将来的にマネジメント業務も担っていただく可能性あり5 - 7 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a medical device manufacturer.
- Responsibilities
- メディカル部門の品質管理担当者として以下の業務に従事いただきます。
業務内容：
ガイドワイヤー、カテーテル等の弊社ブランド製品の品質管理業務品質管理
変更管理
不適合品管理
計測器管理
評価
データ分析
改善等
滅菌プロセスの維持・管理各バリデーション
法規制対応
監査対応 等
品質保証業務法規制対応
監査対応 等
開発プロセスにおけるＱＭＳ視点のチェック、管理
医薬品医療機器等法、ＱＭＳに基づく記録の作成、管理
※ 将来的に現地でのマネジメント業務の可能性もあります※国内外転勤可能性ありますが、当面はございません。
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-150828 Posted: 2024-09-11
Quality Assurance - Eye Care Products | アイケア関連製品における品質保証
日系安定成長企業・顧客満足度を向上させる重要な役割を担っていただきます7 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
- Responsibilities
- 当社アイケア製品の品質保証に関する業務全般をお任せします。
業務内容：
苦情内容に関する調査・分析
苦情情報の調査・分析に関する品質改善指示
苦情の是正と予防対応
出荷停止及び解除に関する業務
回収/改修に関する業務
製造販売後の法規制に関する業務
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-150829 Posted: 2024-09-11
Quality Assurance (Post-Marketing Surveillance) | 品質保証（市販後調査）
高クラス医療機器の市販後調査・将来的に安全管理責任者としてご活躍いただける可能性有5 - 8 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a medical device manufacturer.
- Responsibilities
- 医療機器の市販後監視活動（PMS）安全管理業務（GVP）をご担当いただきます。
業務内容：
文献調査、クレーム分析、トレンド分析、類似医療機器の公開情報分析等
安全管理業務（安全性情報収集・評価・分析）
不具合に関する報告書の作成、国内外の行政機関に対する報告・対応
各国の法規制への対応・各国の行政との折衝
担当チームのマネジメント業務
※将来的には、安全管理責任者としての業務を行っていただく可能性があります。
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-148152 Posted: 2024-09-11
【品質管理】医薬品原薬のGMP運用（管理職候補）◆GQPの取決め／チーム労務管理
海外取引比率約60％・世界約90ヶ所の国や地域との取引実績あり／大手G中核企業10.2 - 13 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is an organic chemicals business company.
- Responsibilities
- ■業務概要：
品質保証課の薬事MF担当として管理職候補としてご活躍いただき、下記業務をお任せします。
医薬品倉庫の医薬品原薬のGMPの運用、管理（QRM、年次照査、GMP適合性調査査察対応、各種手順書および製品標準書の管理、GQPの取決め締結等）
品質クレームへの対応
当局および顧客からの査察対応
■入社後の業務：
自社GMP運用に係る作業および管理業務（製造管理者、品質管理責任者、製造管理責任者等）
課員の労務管理
製販および当局の査察対応
■薬事部の特徴：
医薬品の品質および安全性を確認する上で重要な品質管理業務については、自社で保有する試験室において海外の医薬品原料を厳密に試験し、安全且つ安定的に日本の製薬メーカーに供給できる体制を構築し信頼を得ています。
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-150058 Posted: 2024-09-11
Global Quality Assurance | グローバル品質保証
日系安定成長企業・医療機器の品質保証・顧客視点に立って継続的に品質の改善を進めています8 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
- Responsibilities
- 当社アイケア製品の品質保証に関する業務全般をお任せします。
業務内容：
各販社のQMS遵守状況の確認
各販社の苦情情報の傾向調査及びに品質改善
苦情の是正と予防
出荷停止および解除に関する業務
回収／改修に関する業務
製造販売後の法規則に関する業務
製造所の監視・監督に関する業務
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-149795 Posted: 2024-09-11
Complaint Handler | 苦情処理推進担当
大手アイケアメーカー・品質保証での新たな取り組みをリードいただける方を募集いたします！5 - 9 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
- Responsibilities
- アイケア品質保証課の苦情処理推進担当（またはエキスパート）として以下の業務を担っていただきます。
業務内容：
アイケア製品の品質向上を目的とした、製品の開発から市販後まで幅広い品質監視業務全般
市販前に苦情となりうる製品の問題を抽出し、改善させ、苦情率を低下させる
製品品質に悪影響を及ぼす要因が無いか、ユーザー施設に製品を持ち込み、エンドユーザーの意見を取り入れ、製品に反映する
市販前/後の製品評価業務をリード
Go Ozawa
Industrial & Life Science
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