Work on maintaining and improving the Quality Management System (QMS) to comply with compliance. Identify key process indicators, monitor and analyze, and support to report to management.
Lead Root Cause Investigation, Impact and risk assessment for market, CAPA identification and implementation for issues occurred at Chiba site including production and labs. Also, act as the process champion for non-conformance and CAPA process.
Evaluate and monitor the results of external and internal audits. Support to report the audit results to management and execution of corrective actions associated with the audit results.
Work on maintaining and improving the document management system and document change management process, such as building effective document structure, new document issuance, revision and obsoletion, document review, approval, issuance and effective of document in order to comply with applicable standards/requirements.
Work on maintaining and improving the education and training system to ensure proper product quality and meet applicable standards/requirements. This activity includes developing and implementing a continuous training plan to improve awareness of the Quality Management System. Assign training programs through the training system as needed and support employees to complete their assigned training programs on time.
Work on maintaining and improving the supplier management system to proper manage the suppliers who provide the materials and services associated with the production of products to ensure the quality of our products. Monitor the quality of materials and services provided by the supplier and request corrective action to the supplier as needed.
各システムの品質目標を達成するために、明確なマイルストーンを含む計画の立案及び実行。
To achieve Quality Goals consistent with each quality system, implement concrete plans with clear milestones and lead the plan.
基本的な資格・教育/BASIC QUALIFICATIONS | EDUCATION:
医療、工学、科学、化学などの分野における学士号。
Bachelor's degree in areas such as medical, engineering, science and chemistry.
医療機器・診断薬または医薬品業界での5年以上の経験。
5 plus years of experience in the medical device, diagnostic products or pharmaceutical industry.
品質・品管・製造・技術などの製造業での実務経験。
Work experience in manufacturing environment such as Quality Assurance, Quality control, Manufacturing, Engineering etc.
CAPAおよび根本原因分析に関する知識およびスキルと実務経験。
Knowledge, skill and work experience of CAPA and root cause analysis.
国内外要求事項を満たした品質システムの製造現場での構築・継続管理経験。
Skill and work experience establishing quality systems in manufacturing environment, meeting domestic and global requirements, and also managing the same system .
改善プロセスに関する知識およびスキルと実務経験。
Knowledge, skills and work experience of improvement process.
あらゆる変化に適応する柔軟性と効果的に優先順位を付ける能力。
Flexibility to adapt to any changes and ability to effectively prioritize.
語学力:日本語及び英語に加え韓国語または中国語の語学力があることが望ましいLanguage Competencies : In addition to Japanese and English, having language proficiency in Korean or Chinese is preferable.
結果への推進力:より効果的かつ効率的に進めるために、リソース、ツール、テクノロジーを活用する。
Drives for Results: Leverages resources, tools and technologies in order to progress more effective and efficient.
Fosters Collaboration: Avoids getting stuck in a “one right way” approach and remains open minded to new ideas. Actively develops a network to bring best solutions to the team or customer.
複数のワークグループにまたがる品質、コンプライアンス、および技術分野のメンタリングを提供する。
Provide mentoring in quality, compliance, and technical areas across multiple work groups.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
Ansiennitet
Medarbeider
Ansettelsesform
Heltid
Stillingsfunksjon
Kvalitetssikring
Bransjer
Sykehus og helsetjenester
Henvisninger dobler sjansene dine for å få et intervju i Abbott