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| 部署・役職名 | Senior Manager, Quality Management |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Position: Senior Manager, Quality Management The Senior Manager for Quality Management will be responsible for advancing the quality management system, ensuring compliance with corporate, divisional, and Center of Excellence （CoE） quality standards. Key responsibilities include adherence to MDR 2017/745, ISO 13485, and the MDSAP program, encompassing regulatory requirements from Australia （TG（MD）R Sch3）, Brazil （RDC ANVISA 16/2013）, Canada （MDR）, Japan （J－GMP）, the US （21 CFR § 820）, Taiwan, and other specific country regulations based on target markets. The role reports directly to the Tochigi Plant Head and oversees the Manager of Quality Assurance, Manager of Quality Control, and Team Leaders for qualification and validation, deviation management, complaint handling, change control, employee training, and document and record control. Key Responsibilities: Quality Processes: ● Measurement, analysis, and improvement ＆ reporting. ● Audits, Documentation and document control, Change control, Complaint processing, Deviation control, and Risk management. ● Corrective and preventive action （CAPA） including improvement processes ● Validation and re－validation of processes Personnel Responsibility: ● Personnel management, support, and development for subordinate areas ● Identification of training needs in subordinate areas ● Ensuring and optimizing processes in subordinate areas ● Compliance with company and legislative working time regulations General Tasks/Obligations: ● Compliance with DIN ISO 13485 and other relevant laws, regulations, guidelines, and corporate requirements ● Batch release after EO sterilization ● Process validations/revalidations and adherence to process specifications ● Compliance with ”Code of Conduct” and organizational guidelines ● Occupational safety and adherence to accident prevention regulations ● Compliance with GMP regulations |
| 応募資格 |
【必須（MUST）】 Qualifications ＆ Experience:● Degree in engineering, science, microbiology, or comparable training （Bachelor's/Master's Degree） or extensive working experience can be considered in lieu of formal education. ● QM specialist, Quality manager, and/or Quality auditor Knowledge of ISO 13485, MDSAP, US FDA regulations, etc. ● Professional and disciplinary leadership of employees Advanced project management knowledge. ● Fluency in Japanese and a Business Level proficiency in English. |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/05/16 |
| 求人番号 | 3536902 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です