Company overview
A global biotechnology company focused on developing and commercializing precision, cell-targeting cancer therapies
Key Responsibilities
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Oversee quality control processes related to inspection, storage, packaging, and labeling of medical devices.
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Perform inspections and root cause investigations using mechanical and optical measurement tools, including class IV laser systems.
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Accurately record quality-related activities in both electronic databases and physical documentation systems.
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Ensure ongoing compliance with the facility’s quality management system standards.
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Evaluate the impact of internal and external manufacturing changes on product quality.
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Conduct risk assessments and maintain risk documentation in accordance with ISO 14971.
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Contribute to key quality system functions, including complaint handling, nonconformance investigations, corrective and preventive actions (CAPA), change control, and supplier evaluations.
Qualifications
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Bachelor’s degree in a scientific, engineering, or related discipline.
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At least 2 years of hands-on experience in the medical device sector; additional experience may be considered for a more senior position.
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Working knowledge in the following areas:
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Basic statistical methods
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Use and interpretation of measurement equipment
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Operation and maintenance of mechanical and optical instruments
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Quality management system principles
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Handling of CAPA, complaints, and nonconformances
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Device storage, labeling, and packaging practices
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Proficiency in medical device engineering tasks such as documentation, data analysis, verification and validation (V&V), and risk management.
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Familiarity with the PMD Act and other relevant regulatory frameworks in Japan.
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Strong understanding of ISO 13485 and MHLW Ministerial Ordinance No. 169.
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Excellent communication skills in Japanese; English ability is a plus.