募集要項
- 募集背景
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Position: Senior Manager, Quality Assurance
The Senior Manager, Quality Assurance position maintains and manages the quality management system (QMS) of the company and holds the Marketing Authorization Holder License for importing and distributing products in Japan. It also manages the marketing of local products developed and manufactured at the Tochigi Plant. The role collaborates with the Quality Management Department at the headquarters in Germany to maintain and improve product quality, efficacy, and safety.
- 仕事内容
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Responsibilities:
● Conduct internal training on the quality management system and ensure its effective operation and maintenance.
● Hold Management Review Meetings and collaborate with top management to improve processes and allocate resources.
● Direct internal audits and evaluate observations.
● Approve Corrective Action and Preventive Action (CAPA) plans, and assess their implementation and effectiveness.
● Oversee Change Control activities and provide support as needed.
- 応募資格
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- 必須
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Experience & Skills:
● Minimum of 5 years' experience in medical device quality assurance.
● Experience as a General Supervisor with strong leadership skill is advantageous.
● Business-level English skills for routine communication with global teams.
● Logical thinking, analytical ability, and performance under pressure with ability to meet quality requirements within deadlines.
● Excellent communication, persuasion, and forward-thinking skills and a proactive communicator with strong relationship-building skills.
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Senior Manager, Quality Assurance
- 勤務地
- Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
- 年収・給与
- 12 million yen ～ 13.99 million yen
