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About the Role

The Quality Specialist supports Commercial Quality & Compliance activities in Japan, ensuring compliance with Japanese regulations, Abbott Quality System requirements, and international quality standards for In Vitro Diagnostic (IVD) and Medical Device products. This role is involved in quality activities throughout the product lifecycle and supports the maintenance and continuous improvement of the Quality Management System (QMS).

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.
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.
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.
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.
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.
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.

Requirements

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
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.
Experience supporting suppliers, distributors, warehouses, and third-party logistics providers is preferred.
Basic knowledge of Japanese regulations applicable to Medical Devices and IVD products.
Basic understanding of QMS Ministerial Ordinance No.169 and related regulatory requirements.
Knowledge of ISO 13485 quality management system requirements.
Understanding of ISO 14971 risk management principles is preferred.
Knowledge and practical experience in complaint handling, post-market surveillance, field actions, and recall management.
Basic understanding of supply chain quality management, warehousing, logistics, and distribution quality controls.
Fluent Japanese communication skills (written and verbal).
Ability to communicate effectively in English, both written and verbal.
Strong ownership and accountability.
High ethical standards and commitment to compliance.
Exhibits strong learning agility and a willingness to proactively acquire new knowledge and skills.
Strong collaboration and stakeholder management skills.
Excellent communication and presentation skills.
Strong analytical and problem-solving capabilities.
Ability to manage multiple priorities in a dynamic environment.
Continuous improvement orientation.
Adaptability, resilience, and learning agility.
Strong customer and patient focus.
Demonstrates a team-first attitude, providing support beyond assigned responsibilities when needed and prioritizing overall team success.
Ability to build trust, establish credibility, and maintain productive working relationships.

Skills

Quality Assurance
Quality Systems
Manufacturing Quality
Regulatory Compliance
Medical Devices
In Vitro Diagnostics (IVD)
Investigations
CAPA
Nonconformance Management
Change Control
Risk Management
Audits
Inspections
Japanese Regulations
QMS Ministerial Ordinance No.169
ISO 13485
ISO 14971
Complaint Handling
Post-Market Surveillance (PMS)
Field Actions
Recall Management
Supply Chain Quality Management
Warehousing
Logistics
Distribution Quality Controls
Japanese Language
English Language

Location

Tokyo, Japan

Work Type

Full Time Employee
Occasional Travel

Experience Level

Minimum 5 years of relevant experience

Education Level

Bachelor's Degree or Master's Degree in Pharmacy, Life Sciences, Chemistry, Biomedical Engineering, Biotechnology, Medical Technology, or a related scientific discipline.
Pharmacist License

About the Company

Abbott is a global healthcare leader committed to helping people live more fully at all stages of life.
For more than 125 years, Abbott has 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 employees are working to help people live not just longer, but better, in the more than 160 countries served.
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.

Equal Opportunity

Abbott is an Equal Opportunity Employer and is committed to fostering an inclusive and diverse workplace.
Qualified applicants will receive consideration for employment without regard to protected characteristics protected under applicable laws.
Reasonable accommodations are available for qualified individuals with disabilities.