1. トップ
  2. 求人検索
  3. 求人検索結果
  4. Quality Assurance Specialist (Pre-launch Product Quality)

投稿日:2021/03/25

(社名非公開)

Quality Assurance Specialist (Pre-launch Product Quality)

ポジション情報

職種 品質保証・品質管理
雇用形態 正社員(期間の定め無し)
勤務地 東京都
給与 600万円~900万円
給与(詳細) 前職・経験などをもとに決定
業績賞与あり
職務内容 【Primary Function of Position:】
〇 Manage and implement required actions to maintain existing product lines and to support new product launch / product discontinuation in Japanese market.
〇 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 into Japanese market and to improve product quality:
〇 Lead new product launch / product discontinuation projects and implement quality operations (e.g. product master registration, label / packaging insert registration, technical publication / advertising material review, device history record establishment)
〇 Lead risk management team and implement risk management activities from the viewpoint of product, subcontractors / suppliers and local labeling / product release processes in cooperation with related functions.
〇 Assess change notifications from ISI and manufacturing sites, and implement necessary actions in cooperation with related functions.
〇 Manage, implement and improve local labeling / product release / nonconformity product control processes, including process / computer system validation and data analysis in cooperation with 3PL and related internal functions.
〇 Collaborate with Post-launch Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product quality and local labeling process.
〇 Collaborate with QRC team to maintain Quality Management System.
応募資格 【 Education:】
〇 Bachelor or higher degree (Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology)

【Background:】
〇 Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries
or
〇 Minimum 3 years experience related to Quality in any manufacturing industries

【Skill / Experience:】
<Must:>
〇 Good interpersonal/communication skill to work well with cross-functional teams
〇 Analytical mindset and ability to see the big picture
〇 Project management skill
〇 Logical thinking skill
〇 Strong willing to achieve goals
〇 Verbal and written communication in English and Japanese
〇 Knowledge of basic Quality Management System (e.g. ISO 9001) / Quality Assurance / Quality Control methodology
〇 Basic PC skill (e.g. Microsoft Word /Excel / Powerpoint)

<Preferred:>
〇 Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971
〇 Experience of complaint handling and/or complaint product investigation
〇 Experience of using Oracle Agile PLM, SAP, Trackwise, and/or HP ALM

企業情報

募集企業 (社名非公開)

コンサルタントに相談する

PAGETOP