UMESH GD

• Led QA activities for Diagnostic Cardiology products, ensuring compliance with design quality standards.
• Managed design control tasks, including design change reviews and CAPA.
• Executed internal audits for various CE and FDA products at site.
• Conduct Audit readiness activity across the products for external MDSAP audits.
• Preparation of CCN slides for QMR review.
• Creation of Design control planner for different product milestones FDR1 to FDR3 to ensure products designed with respect to QMS requirements.
• Participate in ECCB, DRB, PRB,CRB meetings and providing the improvement feedback to engineering as per QMS requirements.

Key Achievements:

• Investigated internal audit non-conformances related to site wide CCN issue to identify Root cause and drove CAPA implementation.
• Recognized and awarded with 'lead with lean mindset' twice for contributions to NPI design transfer.
• Ensured audit readiness with no major issues for external Audit.
• Conducted Continous Improvement Project across the Site Related to CCN Handling Process and Design change process.
• Participated in design reviews of new products ensuring compliance with applicable regulations.

• Worked with Medical Product " Medical Grade Smart watch Vital Signs Monitor"
• Led the Product Compliance and FDA certification and ISO 13485 implementation activities.
• Prepared compliance test plans and identified labs for IEC/ISO safety compliance, facilitating successful Product certification.
• Collaborated on development of medical grade smartwatch technology to ensure adherence to quality standards.
• Preparation of Quality Manual and Standard Operating procedure Planning for ISO 13485 certification.
• Evaluated testing cost proposals and resolved ESD failures.
• Creation of Product requirements and specifications.
• Documentation for quality assurance activities and regulatory requirements.
• Collaborated with cross-functional teams to ensure compliance with regulatory standards.

• Worked with a medical device, 'Hemodialysis renal care solution device'.
• Worked for the NPI Program, led CE certification, product V&V, and ISO 13485 implementation.
• Led product verification and validation planning, execution, and reporting.
• Managed internal and external audits for ISO 13485 and CE certification to ensure compliance.
• Led the Safety Compliance activity for IEC 60601-1, IEC 60601-2-16, and IEC 60601-2-25 standards.
• Created CE Technical File per EUMDR requirements.
• System testing and user acceptance testing planning, execution, and reporting.
• Organized and conducted Management Representative Meetings (MRM) to address process compliance and facilitate CAPA management.
• Internal Audit NC's root cause analysis, audit findings, and closure with CAPA and investigation.
• Coordinated with cross-functional teams to identify and resolve quality issues.
• Completed hemodialysis product development and certification activities in alignment with the project plan and milestones.

• Worked with 'MicroSKAN High-Frequency Diagnostic X-Ray Device'.
• Developed product verification and validation protocols to ensure compliance with regulatory standards.
• Preparation of technical file for product CE certification.
• Development of user/service manuals to meet IEC standard requirements
• Conducting Functional and Final QC testing at Manufacturing line.
• Developed and executed parts qualification plans to ensure compliance with specifications.
• Reviewed engineering drawings, process specifications, test requirements, inspection plans, and other technical documents for accuracy.
• Collaborated with cross-functional teams to develop solutions that improve overall product quality.