Senior QA Specialist

Job description

JOB DESCRIPTION: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. Position Title: Quality Specialist - Commercial Quality & Compliance. Position 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. Position 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. KEY RESPONSIBILITIES: 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 inspections, Notified Body audits, and other external assessments. Investigations, Nonconformance Management & CAPA Lead investigations related to nonconformances, deviations, complaints, product quality issues, and other quality events, and coordinate with relevant stakeholders as needed. Conduct root cause analyses and drive the implementation, monitoring, and effectiveness verification of Corrective and Preventive Actions (CAPA). Assess the potential impact of quality events on regulatory compliance, product quality, patient safety, and business operations, and escalate issues appropriately when necessary. Monitor quality trends and quality performance metrics to identify recurring issues and support continuous improvement initiatives. Support the timely processing and closure of quality records, ensuring they are managed in compliance with Quality Management System (QMS) requirements. Change Control & Risk Management Support the review and approval process for changes that may impact product quality, compliance with regulatory requirements, and business processes. Facilitate and document quality risk assessments using risk-based decision-making principles. Ensure that risks are appropriately identified, assessed, mitigated, monitored, and communicated to relevant stakeholders. Support the implementation of risk management activities in accordance with ISO 14971 principles, as applicable. Post-Market Quality, Complaints & Field Actions Support complaint handling and Post-Market Surveillance (PMS) activities for Medical Device and In Vitro Diagnostic (IVD) products. Collaborate with internal and external stakeholders to ensure timely investigation and resolution of customer complaints. Review quality documentation related to product recalls, Field Corrective Actions (FCA), and Field Safety Notices (FSN). Support field actions, product recalls, and corrective action activities as required. Analyze post-market quality data and complaint trends to identify emerging quality risks and opportunities for improvement. Warehouse, Distribution & Supply Chain Quality Oversight Support quality management activities related to local third-party logistics providers (3PLs). Participate in qualification, monitoring, performance evaluation, and continuous improvement activities related to logistics service providers and other external service partners. Ensure that storage, handling, transportation, environmental controls, and distribution activities comply with applicable quality requirements and regulatory requirements. Supplier Quality Management Perform quality management activities related to suppliers, contractors, and service providers. Conduct quality risk assessments and qualification evaluations for new suppliers. Perform periodic supplier evaluations, performance monitoring, and requalification activities. Support investigations of supplier-related quality issues, as well as the implementation of corrective actions and improvement initiatives. Maintain and periodically review Quality Agreements with suppliers and service providers. Conduct supplier audits and follow-up activities as required. QUALIFICATIONS Education Bachelor's Degree or Master's Degree in Pharmacy, Life Sciences, Chemistry, Biomedical Engineering, Biotechnology, Medical Technology, or a related scientific discipline. Pharmacist License is highly desirable Professional Experience Minimum 5 years of relevant experience in Quality Assurance, Quality Systems, Manufacturing Quality, Regulatory Compliance, or related quality functions within a regulated healthcare industry. Experience within Medical Devices and/or In Vitro Diagnostics (IVD) is strongly preferred. Demonstrated experience in investigations, CAPA, nonconformance management, change control, risk management, and quality systems. Experience supporting audits, inspections, and regulatory compliance activities. Experience working within a multinational or matrix organization is highly desirable. Expe