Senior QA Specialist

About Abbott: Abbott is a global healthcare leader committed to helping people live more fully at all stages of life. At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 103,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Title : Quality Specialist - Commercial Quality & Compliance.

Type: Full Time Employee. Division: Abbott Rapid Diagnostics (ARDx). Function: Commercial Quality & Compliance. Reports to: Manager Commercial Quality & Compliance. Department: Quality Assurance. Primary Location (Supporting Locations): Tokyo, Japan. Travel Required: Occasional. Abbott Rapid Diagnostics (ARDx) is part of Abbott's Diagnostics business and brings together world-class expertise and industry-leading technologies to support diagnostic testing and provide critical information for the treatment and management of diseases and other health conditions. This position is part of the Commercial Quality & Compliance organization supporting Abbott's In Vitro Diagnostics (IVD) and Medical Device portfolio in Japan.

Summary: 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.

Support the implementation, maintenance, and continuous improvement of the Commercial Quality Management System (QMS) for Medical Device and In Vitro Diagnostic (IVD) products in Japan. Ensure compliance with applicable Japanese Medical Device and IVD regulations, QMS Ministerial Ordinance No. 169, Abbott Quality System requirements, and relevant global quality standards. Support and promote Quality Assurance activities throughout the entire product lifecycle, from product launch through product discontinuation. Review Global Quality Management System (QMS) procedures and assess their impact on local Japanese regulatory requirements. Support the maintenance and control of QMS documentation, procedures, and quality records. Assist in ensuring that quality-related documentation is maintained accurately and remains up to date. Support activities related to internal audits, supplier audits, third-party audits, and regulatory inspections. Support PMDA