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東京都の品質管理の求人203件応募資格・募集要項・仕事内容を見る
Senior QA Specialist
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 正社員
どんな仕事かAIによる生成
The Quality Specialist supports Commercial Quality & Compliance activities in Japan for In Vitro Diagnostic (IVD) and Medical Device products. The role supports maintenance and continuous improvement of the Quality Management System and conducts quality-related activities including investigations, CAPA, risk management, post-market quality, distribution, and supplier quality management.
この求人に応募
応募資格
必須
- Bachelor's Degree or Master's Degree in Pharmacy, Life Sciences, Chemistry, Biomedical Engineering, Biotechnology, Medical Technology, or a related scientific discipline.
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.
- Demonstrated experience in investigations, CAPA, nonconformance management, change control, risk management, and quality systems.
- Experience supporting audits, inspections, and regulatory compliance activities.
Technical Knowledge
- 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.
- 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.
Language Skills
- Fluent Japanese communication skills (written and verbal).
- Ability to communicate effectively in English, both written and verbal. Candidates who possess sufficient English proficiency to participate in meetings with global teams, handle business correspondence, and review documentation in English will be highly valued.
歓迎
- Pharmacist License is highly desirable
Professional Experience
- Experience within Medical Devices and/or In Vitro Diagnostics (IVD) is strongly preferred.
- Experience working within a multinational or matrix organization is highly desirable.
- Experience supporting suppliers, distributors, warehouses, and third-party logistics providers is preferred.
- Understanding of ISO 14971 risk management principles is preferred.
求める人物像
- 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.
募集要項最終確認 11/4
- 職種
- 品質管理
- 雇用形態
- Position Type: Full Time Employee.
- 給与
- 記載なし
- 給与の詳細
- The base pay for this position is N/A
- 勤務地
- 2-4-1 Nishi-Shinjuku, Shinjuku-ku
- 働き方
- 記載なし
- 勤務時間
- Standard
- 経験年数
- 5年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/10/13 06:25（23日前）
- 最終確認
- 2026/11/04 20:22（1日前）
仕事内容
募集内容
- 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.
この求人は、アボットジャパン合同会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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