Quality Assurance Specialist

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:

• 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 ISI 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 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.

Background:

• Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries or 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
• 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)

Required Education and Training:

• Bachelor or higher degree (Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology)

Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)

• 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