【COMPANY OVERVIEW】
A Japanese manufacturer of premium quality needles and cannulas for the global aesthetic market.
【JOB RESPONSIBILITIES】
Responding to audits, inspections, and conformity surveys by domestic and foreign regulatory authorities, certification bodies, and customers.
Management of audit, inspection and conformity assessment plans.
Responding to inquiries from customers, overseas offices, and suppliers regarding quality and laws and regulations
Management and supervision of quality assurance, safety control and regulatory compliance operations
Management representative (QMS Management Representative) as required by the ISO, FDA/QSR and ・QMS Organization Ordinance
Maintenance and management of the quality management system
Handling general QA principles like change control, CAPA, Complaints
Contribute to internal audit
Supplier management (new suppliers) and audit of Japanese suppliers
Oversee manufacturing records and QC testing
Work related to compliance with regulations in various countries, including development of regulatory strategies.
Public relations with domestic and foreign regulatory authorities and certification bodies
【REQUIREMENTS】
More than 3 years of practical experience in QA work at medical devices company or pharmaceutical company.
Experience in Japan domestic RA or/and MDR RA
Experience working as a general marketing supervisor of medical devices and/or Domestic quality assurance manager.(Plus)
Management representative (QMS Management Representative) as required by the ISO 13485, FDA/QSR.(Plus)
Knowledge of the Pharmaceutical and Medical Device Act, ISO 13485, and other laws and regulations of each country
Business level of English and Japanese