Mexico City Area, Mexico Mexico
RA/QA Specialist en Nihon Kohden Mexico
Medical / Health Care / Pharmaceuticals
• Handling, Preparation and Control Files
• Preparation of dossiers for sanitary registration of medical equipment by the Ministry of Health
• Management of proceedings for modification of operational notices, legal guardian and legal representative.
• Electronic file creation and management
• Capture, storage and retrieval of regulatory official documents
• Management and coordination with the team export and import of medical equipment for trade fairs abroad
• Implementation of NOM 241 SSA1 2012 for Good Manufacturing Practices for medical equipment as part of the Control of Quality Implementation Team
Health and Safety at Work NOM 026 STPS 2008
ISO 10993
ISO 14971
ISO 13485