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Lead and grow a vital Quality Management System (QMS) for a dynamic, innovative medical device company in Japan. You will be a key player in establishing, maintaining, and improving the company's Quality Management System (QMS) in Japan, ensuring compliance with all relevant regulations. You will lead critical quality operations, collaborating closely with cross-functional teams and external stakeholders. This is a high-impact role where you'll directly contribute to ensuring the safety and efficacy of life-changing medical devices.
Job Responsibility:
Lead the implementation and maintenance of the QMS, ensuring compliance with Japanese regulations
Manage document control, training programs, and change management processes
Conduct internal and external audits, and drive continuous improvement initiatives
Support manufacturing activities, including quality checks and product release decisions
Collaborate with regulatory affairs and safety teams on product lifecycle management
Manage supplier relationships and ensure compliance with quality standards
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