Safety Specialist

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募集要項

会社概要

手術システムメーカーです。特に低侵襲手術に力を入れており、パイオニア的存在です。

業務内容

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. 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:
Main responsibilities:

• 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 company 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 etc.)
• Work related to data analysis and CAPA.

応募条件

Minimum requirements:

• Bachelor or higher degree (Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology)
• Either of the following experiences:
  • Minimum 3 years’ experience in Pharmaceutical/Medical Device/IVD industries
  • Minimum 3 years’ experience related to Quality in any manufacturing industries
• 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)

Preferred qualifications:

• 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

給与

600 - 1000 万円

勤務地

東京