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~フルリモート可能~ QAspecialist

年収:800万 ~ 1000万

ヘッドハンター案件

部署・役職名 ~フルリモート可能~ QAspecialist
職種
業種
勤務地
仕事内容
• Manage and implement required actions to maintain existing product lines and to support new product launch into the Japanese market.
• Take timely and appropriate quality management actions and executing communications with government and internal/external customers.
Roles and Responsibilities:
This position has following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality:
• Implement product realization operations. (e.g. product master registration, label/packaging insert registration, technical publication/advertising material review, device history record establishment)
• Implement risk management from the viewpoint of product, contractors/suppliers and local labeling/product release processes in cooperation with related functions.
• Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
• Manage and implement local labeling/product release/nonconformity product control processes, including process/computer system validation and data analysis in cooperation with 3PL and related internal functions.
• Evaluate Japanese customer complaints from the viewpoint of product quality, report to headquarters and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control and QRC teams.
• Completing quality issues by working with regulatory agencies, customers and related functions.
• Involve in implementation of a field action.
• Support establishment of regulatory/quality filing (e.g. local/oversea licenses, QMS investigation) based on Japanese Pharmaceutical and Medical Device Act (hereafter J-PMD Act) and relevant regulations in cooperation with headquarters and related functions.
• Support establishment, maintenance and improvement of global/local quality management system based on J-PMD Act, relevant regulations and company policy in cooperation with QRC team.
労働条件 雇用条件:正社員
受動喫煙対策に関する表示:屋内禁煙
応募資格

【必須(MUST)】

Skill/Job Requirements:
• 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
 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)
o Preferred:
 Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971
 Experience of using SAP

更新日 2021/09/09
求人番号 1877278

採用企業情報

この求人の取り扱い担当者

  • 3.22
    ?
  • ヘッドハンターの氏名は会員のみ表示されます
  • 会社名は会員のみ表示されます

    • 東京都
    • 駒澤大学法学部法律学科
  • メーカー メディカル
    • スペシャリスト~ミドル、エグゼの方まで支援しております。 ◆ヘッドハンターサミット  メディカル部門MVP 2年連続受賞◆
    • (2021/03/14)

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