• 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.
o Bachelor or higher degree （Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology）
o Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries
o Minimum 3 years experience related to Quality in any manufacturing industries
• Skill / Experience:
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）
Knowledge of J－PMD Act, relevant regulations, ISO 13485 and ISO 14971
Experience of using SAP