Responsible to develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensure compliance to applicable standards.Management Representative - Ensure processes addressing the Quality Management System requirements are effectively established, implemented, and maintained in accordance with the Global Quality standards and applicable regulations Member Leadership team -Develop strategies & enable solutionsManage product quality/ improvement while maintaining safety and regulatory compliance. Establish and deliver compliance / Product Quality metrics.Manage external Inspections & Audits – Experience with ISO standard ( 13485 , 9001 ) , MDSAP , FDA, IMDR , NMPA, KFDA, Anvisa, MHLW, TFDA

Responsible for overall CAPA Management System of two site.

Responsible for overall QMS compliance and deployment for three modalities (sub-systems and finished medical devices). Responsible for Design Transfer and Production Transfer activities at site.

Responsible for establishing advanced manufacturing capabilities. Responsible for process validation, equipment qualification activities and verification activities. Driving brilliant factory initiatives and simplification projects.

Factory Quality : Successfully led Part/Product/Process qualifications and VSM activities towards quality and cost improvement through efficient use of ACE (Achieving competence excellence) tools.QMS representative : Co-ordinated successful completion of ISO 9001:2005, ISO 14001:2000, ACE UTC quality system silver certification for manufacturing and business processes, and led internal audits .Customer Quality :Point of contact between the customer and the factory. I lead the cross functional teams towards resolution of field issues through Quality Action Office, an initiative followed at Bangalore Otis.Supplier Quality : Lead supplier evaluation and certifications through Process , QMS , EMS and Q+ audits. Continuously monitored the supplier capability and drove actions to improve the process and productivity achieving the target.

As a Graduate Engineering Trainee I have worked on PCB autopsy , RCA , Customer issues , ICT programming and development , new product design , Design and development of testers.