社名
社名非公開
求められる経験
Requirements
・Minimum 5 years of experience in quality assurance within the medical device or IVD industry.
・Proven experience in QMS establishment, maintenance, and improvement.
・Experience leading internal and external audits.
・Experience in product realization processes, including risk management.
・Strong understanding of Japanese medical device regulations (J-PMD Act, etc.).
・Excellent communication skills in Japanese and English.
・Strong leadership, problem-solving, and analytical skills.
・Experience with CAPA (Corrective and Preventive Actions).
・Experience with documentation and record-keeping systems.
・Bachelor's degree in a related scientific or engineering field.
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