- なぜ募集しているのか
- You will oversee quality assurance tasks related to medical devices, in vitro diagnostics, veterinary medicines, and research reagents, including consumables and equipment. You will collaborate with other quality assurance personnel to operate and maintain the QMS, ensuring compliance with industry standards and regulatory requirements.
- どんな仕事か
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Responsibilities:
● Create and revise QMS documents.
● Develop and execute market launch plans with relevant departments.
● Create and revise legal labeling.
● Conduct risk analysis for product launches and modifications.
● Perform internal audits and evaluate suppliers.
● Manage domestic manufacturing contractors.
● Report defects to overseas sites, investigate causes, and implement corrective actions.
● Respond to QMS conformity assessments.
● Prepare documents for QMS conformity assessments required for manufacturing and marketing authorization. - 求められるスキルは
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必須 Required Qualifications and Experience:
● Over three years of quality assurance experience in the medical device or in vitro diagnostics field.
● Experience with ISO 13485 conformity assessments by regulatory authorities or certification bodies.
● Business-level English proficiency for reading technical documents, handling emails, and participating in teleconferences.
Preferred Qualifications and Experience:
● Team leadership or management experience (people management experience not mandatory).
● Knowledge of research equipment and analytical reagents used by our company or competitors.
● Experience using ERP systems like SAP. - 雇用形態は
- 正社員
- どんなポジション・役割か
- Senior Quality Assurance Specialist
- どこで働くか
- 東京都
- 給与はどのくらい貰えるか
- 800万円 ～ 999万円
掲載期間24/06/25～24/07/08
求人No.RSP-TSSRQAS
