Senior QA Specialist / 迅速ポイントオブケア診断製品
アボットダイアグノスティクスメディカル株式会社
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品質保証・品質管理
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東京都
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650万円~900万円
○ The Quality Specialist supports Commercial Quality & Compliance activities in Japan and assists in maintaining compliance with applicable Japanese regulations, Abbott Quality System requirements, and international quality standards for In Vitro Diagnostic (IVD) and Medical Device products.
○ This position is involved in quality activities throughout the product lifecycle and supports the maintenance and continuous improvement of the Quality Management System (QMS). The role is responsible for a variety of quality-related activities, including nonconformance management, quality investigations, CAPA (Corrective and Preventive Actions), change control, quality risk management, document control, complaint handling, post-market quality activities, distribution and logistics quality management, and supplier quality management.
○ The incumbent works closely with Regulatory Affairs, Supply Chain, Commercial Operations, Global Quality, Manufacturing Sites, Marketing Authorization Holders (MAH), and third-party logistics providers to contribute to the maintenance and enhancement of product quality, patient safety, customer satisfaction, business continuity, and regulatory compliance.
○ The successful candidate shall demonstrate strong learning agility and ownership, and who can collaborate effectively with team members and stakeholders to support problem-solving and continuous improvement initiatives. In addition to quality expertise, the successful candidate should be able to communicate effectively and continue developing professionally within a global, cross-functional environment.