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About the Role

Perform quality assurance and quality control activities for ADC products, and contribute to maintaining safety management operations. Maintain the quality system of Abbott Japan LLC, and possess a strong understanding of ADC global quality systems, while collaborating with relevant departments to ensure product supply is carried out as planned.

Responsibilities

• Prepare product specifications and establish testing and inspection items.
• Conduct gap analysis and confirm compliance with regulatory requirements when preparing or revising product specifications.
• Collect and evaluate quality information, reporting and escalating as necessary.
• Take responsibility for conducting analysis and investigations, developing action plans, and completing effectiveness evaluations for corrective and preventive actions (CAPA).
• Evaluate change control information, identify tasks, share information, and facilitate the process.
• Prepare procedures for Abbott Japan LLC and conduct gap analysis for ADC division-specific procedures.
• Develop plans for recalls, modifications, and product replacements, and manage their execution.
• Evaluate safety information and collaborate with the safety management team to complete necessary tasks.
• Periodically verify manufacturer compliance with the Pharmaceuticals and Medical Devices Act (PMD Act).
• Implement product hold measures and evaluate quality information for nonconforming products.
• Conduct internal audits and support audits for other business divisions.
• Plan, support, and conduct audits of external suppliers.
• Provide support and response for audits conducted by external authorities.
• Manage suppliers, verifying compliance with specified requirements.
• Review documents for QMS conformity assessments and foreign manufacturer registration.
• Promote document control, training, license management, and quality system maintenance.
• Develop and implement operating methods that satisfy regulatory and quality system requirements.
• Conduct release decisions for ADC products and OEM products.
• Establish quality agreements with manufacturers.
• Supervise and oversee outsourced operations.
• Handle complaint processing and monitor complaint trends.
• Review risk assessment results and evaluate proposed risk mitigation measures.
• Ensure training is conducted by maintaining LMS modules and assigning training.
• Maintain personnel qualifications and manage required records.
• Participate in external working groups.
• Communicate effectively with stakeholders to obtain the latest information.
• Execute actions for new product introduction and product discontinuation.
• Conduct management reviews and report to ADC Global.
• Assess translations and specifications for labeling changes and conduct domestic impact assessments.
• Collect safety management information and create corresponding records.
• Review collected safety information and document the results.
• Report adverse event information to the Safety Management Officer or MAH.
• Ensure compliance with reporting deadlines and submit adverse event reports electronically.

Requirements

• Minimum of three years of experience in safety management or equivalent functions for Senior Specialist.
• Strong presentation skills are required for Senior Specialist.
• English proficiency sufficient for business communication with overseas stakeholders (TOEIC score of 730 or higher).
• Computer skills: Excel (data analysis, PivotTables, functions), Word (document creation and editing), PowerPoint (presentation slide creation).
• Demonstrated ability to perform quality assurance and manufacturing control operations appropriately and effectively.
• Experience in quality assurance in the medical device industry or other manufacturing industries is required.
• Ability to understand compliance with regulations and other applicable laws, as well as quality systems, and to make appropriate and sound decisions.
• Ability to collaborate with related departments and lead quality assurance activities effectively.
• Ability to understand the situation in which a problem has occurred, identify root causes, and develop measures to prevent recurrence.
• Ability to develop and implement improvement initiatives to enhance operational efficiency and reduce human error.
• Ability to communicate effectively and smoothly with various internal stakeholders, including global teams.

Skills

• Quality Assurance
• Quality Control
• Safety Management
• Quality System Management
• Regulatory Compliance
• CAPA Management
• Change Control
• Auditing
• Supplier Management
• Risk Assessment
• Training Management
• Document Control
• Excel
• Word
• PowerPoint
• Presentation Skills
• Communication Skills
• Analytical Skills
• Planning Skills
• Judgment
• Leadership

Location

• Japan

Work Type

• Full-time

Experience Level

• Senior Specialist

Education Level

• Bachelor's degree (four-year university) or equivalent

Benefits

• Career development with an international company
• Company recognized as a great place to work in dozens of countries
• Named one of the most admired companies in the world by Fortune
• Recognized as one of the best big companies to work for
• Recognized as a best place to work for diversity, working mothers, female executives, and scientists

About the Company

• Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.
• We’re always looking towards the future, anticipating changes in medical science and technology.
• We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
• We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.