Six Sigma Black Belt Certified, Total Quality Representative Management experience include:- Implement, Monitoring of various Certification eg. ISO 9001:2015, ISO 13485:2016, ISO 14001:2015- Facilitation of Six Sigma and Process Improvement projects,- Various Business Excellence Awards , National Quality Award.Specialty:- CE marking, ISO 13485, Medical device Regulatory ServiceMedical Device Consultant ( CE | USFDA | INDIAN MDR | ISO 13485 | CDSCO | 510K)

Six Sigma Black Belt Certified, Total Quality Representative Management experience include:- Implement, Monitoring of various Certification eg. ISO 9001:2015, ISO 13485:2016, ISO 14001:2015- Facilitation of Six Sigma and Process Improvement projects,- Various Business Excellence Awards , National Quality Award.Specialty:- CE marking, ISO 13485, Medical device Regulatory ServiceMedical Device Consultant ( CE | USFDA | INDIAN MDR | ISO 13485 | CDSCO | 510K)

Implementation of Quality Management System ( Quality Manual, Procedure, SOPs)Internal AuditRegulatory AffairInterreact with all department Sales, Marketing, HR, Admin, Purchase, Maintenance, Management for Implementation of QMS.Responsible for label release for product for regulatory Compliance.

Making plans using detailed drawingsPreparing estimates and budgetsCreating accurate project specificationsDesigning engineering experimentsCreating technical reports for customersCompleting regulatory documents concerning safety issuesFinishing projects on time and within budgetCommunicating with clients and coworkers about analysis results

Responsible for Implementation of Quality Management System.Responsible for managing the quality assurance programI interact with colleagues from customer service center, sales & Marketing, Supply Chain, regulatory affairs to ensure compliance with all applicable regulatory requirements and company policies and procedures.Quality Management System ( Quality Manual, Quality Policies, SOPs), Auditing.Six Sigma Initiative and Quality related training at organization level