Sr. QA Specialist (ADC: Abbott Diabetes Care)

JOB DESCRIPTION: About Abbott 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. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Diabetes (ADC: Abbott Diabetes Care) 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. Department Objectives Maintain stable product and process quality and achieve continuous quality improvement through early detection and correction of nonconformities. Primary Purpose of 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. Expected Outcomes Maintain and manage the ADC Quality Management System, establish processes compliant with Abbott Japan's quality system, and drive further improvement in product quality. Core Job Responsibilities Under the direction of the Domestic Quality controller, perform the following duties: Prepare product specifications and establish testing and inspection items. When new preparation or revision of product specifications is required, conduct a gap analysis and confirm compliance with regulatory requirements and approved matters. Collect and evaluate quality information. In accordance with procedures, report to the Head of Domestic Quality Operations and the General Marketing Authorization Holder (MAH) as necessary, and escalate globally to discuss appropriate actions. When corrective and preventive actions (CAPA) are required, take responsibility for conducting analysis and investigations, developing action plans, and completing effectiveness evaluations. Evaluate change control information, identify tasks associated with the changes, share information with relevant departments, and facilitate the process including completion of the changes and subsequent monitoring. Prepare procedures for Abbott Japan LLC, and when the development of ADC division-specific procedures is required, conduct a gap analysis to ensure that global procedure requirements are fully covered and that compliance with applicable regulations is achieved. Develop plans for recalls, modifications, and product replacements; provide instructions to relevant departments; escalate to the three responsible executives; prepare protocols for the sales team; manage progress; communicate with regulatory authorities and global teams; determine methods for handling returned products; and establish a system to promptly execute recalls, modifications, or product replacements from the market. In the evaluation of safety information, when actions such as sales suspension, revision of package inserts, provision of safety information, or reporting to regulatory authorities are required, collaborate with the safety management team to complete the necessary tasks. Periodically verify that manufacturers comply with the Pharmaceuticals and Medical Devices Act (PMD Act) and properly implement manufacturing control. In the event that the release of nonconforming products from a manufacturer is identified, promptly implement product hold measures and evaluate quality information in order to assess relevant safety information. Conduct internal audits in accordance with internal audit procedures, and contribute to supporting audits for other business divisions. When an audit of external suppliers is required, plan, support, and conduct such audits. When audits conducted by external authorities—such as the MHLW, Chiba Prefecture, or certification bodies—take place (e.g., for Marketing Authorization Holder license renewal), provide appropriate support and response. Manage suppliers. For supplier selection, verify that the procedures and the requirements specified by the procurement department are adequately met. Review whether the necessary documents for QMS conformity assessments and foreign manufacturer registration have been appropriately collected. Within the assigned scope, promote document control, training, license management, and the maintenance and continuous improvement of the quality system, ensuring that business processes are aligned with the quality system. Develop and implement practical operating methods that satisfy both regulatory requirements and quality system requirements. Conduct release decisions for ADC products and OEM products. Establish quality agreements with manufacturers to support the supply of products that comply with manufacturing and quality control requirements. Supervise and oversee outsourced operations at the Matsudo site. Collaborate, as necessary, with suppliers selected by the contracting party to ensure the maintenance and control of product quality. Handle complaint processing in collaboration with the data entry/registration function. Regularly obtain global complaint trend data and monitor for any changes in domestic complaint trends. Review risk assessment results provided by manufacturers and evaluate whether Japan-specific risk assessments are required and whether the proposed risk mitigation measures are appropriate. Ensure that training is appropriately conducted by maintaining Learning Management System (LMS) modules, identifying target trainees, and assigning training to new employees. Maintain the qualifications of relevant personnel and manage required records to ensure the quality system is properly maintained. Participate in external working groups to maintain influence. Communicate effectively with both internal and external stakeholders to obtain the latest information. Execute actions identified in plans for new product introduction and product discontinuation led by the responsible department. Conduct management reviews and report to ADC Global. Also prepare materials for the Marketing Authorization Holder's (MAH) management review. As the label process owner in cases where revisions are required due to changes in labeling, packaging, digital content, and statutory labeling, assess with manufacturers whether translations and specifications are acceptable. For domestic impact assessments, proceed in consultation with reviewers identified by the responsible department. As necessary, perform the following tasks under the direction of the Safety controller: Collect the following safety management information and create corresponding records: Information from healthcare professionals Information from academic society reports, literature, and other research findings Information from the MHLW, other government agencies, prefectural authorities, and PMDA Information from foreign governments and organizations Information from other Marketing Authorization Holders (MAHs) and related entities Review the collected safety information without delay and document the results. If, as a result of the review, it is determined that adverse event reporting or other actions are required, report in writing to the Safety Management Officer or the General Marketing Authorization Holder (MAH) and retain a copy of the report. Ensure compliance with reporting deadlines and submit adverse event reports electronically via the Medical Device Adverse Event Reporting System. Required/Preferred Background and Competencies For Senior Specialist: Minimum of three years of experience in safety management or equivalent functions, and strong presentation skills are required 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). A bachelor's degree (four-year university) or an equivalent level of education. 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. Judgment:The ability to understand compliance with regulations and other applicable laws, as well as quality systems, and to make appropriate and sound decisions. Leadership: The ability to collaborate with related departments and lead quality assurance activities effectively to drive operations forward. Analytical Skills:The ability to understand the situation in which a problem has occurred, identify root causes, and develop measures to prevent recurrence. Planning Skills:The ability to develop and implement improvement initiatives to enhance operational efficiency and reduce human error. Communication Skills:The ability to communicate effectively and smoothly with various internal stakeholders, including global teams. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Quality Assurance DIVISION: ADC Diabetes Care LOCATION: Japan > Tokyo : Mita South Tower, Minato-ku ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. 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