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Quality Assurance Specialist （Product Quality）
年収：800万 ～ 1200万
採用企業案件
インテュイティブサージカル合同会社
-
- 会社規模101-500人
- 機械
- 精密・計測機器
- 医療機器メーカー
| 部署・役職名 | Quality Assurance Specialist （Product Quality） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Primary Function of Position: - Manage and implement required actions to maintain existing product lines and to solve any product quality issues occurred in Japanese market. - Take timely and appropriate quality management actions and executing communications with government and internal / external customers. Roles and Responsibilities: This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality: - Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions. - Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions. - Evaluate customer complaints from the viewpoint of product quality, report to ISI and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team. Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams. - Completing quality issues by working with regulatory agencies, customers and related functions. - Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product. - Involve in implementation of a field action like a recall. - Collaborate with QRC team to maintain Quality Management System. - Work related to product realization (control DMRs and materials for released products etc.) - Operate product release (IQC, labeling instructions, and market release assessment etc.) - Manage non-conforming products (rework, concession, and hold The Supply Chain Management Specialist will conduct meticulous analysis of weekly, monthly, and quarterly forecast accuracy, facilitating informed ordering decisions under the guidance of management. Roles and Responsibilities: - Execute inventory management tasks for designated product lines in adherence to established procedures and guidelines, collaborating closely with managerial or senior staff support. - Actively participate in supply chain-related meetings, including Sales, Inventory, and Operations Planning (SIOP), offering valuable insights and contributions. - Contribute to demand forecast analysis and maintenance, continuously monitoring inventory levels to prevent backorders and minimize excess or expired inventory. - Collaborate cross-functionally with Regulatory Affairs, Quality Assurance, Marketing, and other teams to address supply chain requirements for new product launches and revisions. - Independently resolve minor issues, while promptly escalating complex or critical matters for guidance from managerial or senior staff. - Collaborate with team members to identify opportunities for quality management, risk mitigation, cost reduction, and process enhancement. - Serve as a liaison with corporate team members to facilitate system delivery and returns, ensuring adherence to timelines and objectives. - Coordinate with Area Sales Managers, Carriers, and third-party logistics (3PL) partners to facilitate the timely delivery and trade-in of system carts. - Manage relationships with 3PL partners and forwarders to optimize importing and warehouse operations, actively seeking opportunities to enhance efficiency and quality. - Conduct comprehensive trend analysis and report key performance indicators (KPIs) to management on a monthly basis, offering contextual insights and proposing strategies for improvement as needed. |
| 応募資格 |
【必須（MUST）】 ? Education:o Bachelor or higher degree (Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology) ? Background: o Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries or o Minimum 3 years experience related to Quality in any manufacturing industries ? Skill / Experience: o Must: ? Good interpersonal/communication skill to work well with cross- functional teams ? Analytical mindset and ability to see the big picture ? Project management skill ? Logical thinking skill ? Strong willing to achieve goals ? Verbal and written communication in English and Japanese ? Knowledge of basic Quality Management System (e.g. ISO 9001) / Quality Assurance / Quality Control methodology ? Basic PC skill (e.g. Microsoft Word /Excel / Powerpoint) • Business-level proficiency in written and verbal English; native-level proficiency in Japanese. • Demonstrated ability to work effectively as a utility player, adapting to various roles and responsibilities. 【歓迎（WANT）】 - Previous experience in the medical device/supplies industry.- Experience in SAP or other enterprise resource planning (ERP) systems. - Negotiation skills and experience in English. - Experience in third-party logistics (3PL) management. - Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971 - Experience of complaint handling and/or complaint product investigation - Experience of using Oracle Agile PLM, SAP, Trackwise, and/or HP ALM |
| アピールポイント | 自社サービス・製品あり 外資系企業 シェアトップクラス 新規事業 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/07/02 |
| 求人番号 | 3596695 |
採用企業情報
- インテュイティブサージカル合同会社
-
- 会社規模101-500人
- 機械
- 精密・計測機器
- 医療機器メーカー
-
会社概要
【設立】2010年5月31日
【代表者】職務執行者 滝沢 一浩
【本社所在地】東京都港区赤坂
【事業内容】ダビンチサージカルシステムの販売および保守サービス、医療者へのテクノロジートレーニングの提供等
Intuitive Surgical社（NASDAQ:ISRG）はロボット支援低侵襲外科手術技術の分野での世界的リーダーです。
わが社のda Vinci サージカルシステムは、外科医に対して、低侵襲外科手術を最適に実施するための快適な動きを提供すると共に
優れた3D(三次元)高解像度画像、極めて巧妙な動き、そして高い精度と操作性を提供しています。
ダビンチサージカルシステムについて
ダビンチサージカルシステムは、「ロボット」「コンピューター」「光学」の各技術を応用して、外科医が行う低侵襲手術を支援する医療機器です。執刀医に鮮明な術野画像を提供する高倍率3DHD技術、人間の手首以上の可動域と手ぶれ補正機能を備えた専用インストゥルメント（鉗子）等により、低侵襲アプローチでより複雑かつ繊細な動きを要する手術を可能にします。
米国では2000年、日本では2009年に薬事承認を受け、過去26年間で世界で約850万件のダビンチ手術が行われています。
日本では、2012年の前立腺がん、2016年の腎臓がんに続き、2018年には食道がん、心臓弁形成術、肺がん、胃がん、直腸がん、膀胱がん、子宮体がん、膣式子宮摘出術等、また、2020年には、すい臓がん､仙骨固定術、腎盂尿管吻合術等へのダビンチの適用が、公的医療保険の対象となりました。
現在日本では、第 4 世代モデルとなる「ダビンチ Xi」および「ダビンチ X」 の販売を行っています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です