Quality Assurance Specialist (Pre-launch Product Quality)
|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)
〇 Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries
〇 Minimum 3 years experience related to Quality in any manufacturing industries
【Skill / Experience:】
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)
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