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.

Qualifications :

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

その他の情報 :

当社は法令に従い全ての応募者についてその適性と能力のみを基準として公正に採用選考を行います

この職位は業務上のニーズや採用候補者の経験知識技能に応じてここに記載されている職務レベルと異なるレベルで採用される場合があります

報酬は主に採用された職務レベルと候補者の資格に基づき適用される法律に従って決定されます

Remote Work :

No

Employment Type :

Full-time