Somnath Utage
Qa Manager @Trivitron Healthcare
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WORK HISTORY
Qa Manager @Trivitron Healthcare
Navi Mumbai, IN
QMS Implementation-Support the Radiology Design Control process from feasibility throughmanufacturing release, while ensuring procedural and regulatory compliance-Quality reporting, CAPAs, Engineering Change Management, validations, specificationdevelopment- On-going development of the Quality Management System, and support ISO 13485Certification- Report to Management on the performance of the quality management system and any need for improvement- Develop product and process inspection plans and criteria- Support and approve audits: internal, external, and supplier- Maintain an in-depth understanding of the quality and documentation systems, applicablestandards and requirements- Preparation and maintenance of regulatory files/database/DMF/Technical files chronologiesin good order. As per MDR 2017
EDUCATION
T.A. Patil Institute
Bachelor of Technology - BTech
SKILLS
ABOUT SOMNATH UTAGE
Experienced Quality Assurance manager with more than 14 years of working experience in the medical device manufacturing. Proficient in ISO 13485:2016, ISO 9001:2015 Quality management systems, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), internal auditing, 8D root cause analysis, continuous improvement initiatives, corrective and preventive actions (CAPA), and documentation. A dedicated quality professional with a strong commitment to excellence.
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