Samyuktha Dodda

• Cross functional core team lead responsible for creating, reviewing and establishing compliance as part of GSPR and EU MDR activities.
• Trained cross functional teams on GSPR.
• Analyzed complaint trending , quality data reporting and other metrics to assess health of the system.
• Completed gap analysis and closure for non-conformances to prepare for BSI certification and renewal.
• Applied design controls, and risk management techniques in the support of sustaining legacy medical devices.
• Reviewed Post market data that fed into Risk management and design changes.
• Generated and updated Essential Performance and Risk Management documents and reviewed Post Market Surveillance plans and reports to demonstrate compliance to 60601 standards.
• Applied design controls, and risk management techniques in the support of sustaining legacy medical devices.
• Generated labeling verification reports to support quality standards.
• Used Windchill to manage the life cycle of all the deliverables.
• Working experience in complete design controls life cycle, Design History File (DHF) remediation, design remediation/change projects, risk management consolidation, and production and supplier quality remediation projects for Class III devices.
• Participate in design reviews to ensure adherence to design control requirements.
• Support CAPA and NCM activities as part of sustaining development projects. Initiate and lead projects involving failure investigations, root cause analysis and risk review activities using appropriate investigative techniques and statistical methods.
• Coordinated risk management activities and linked all the Risk Control Measures to the Design Inputs in the Risk Control Trace Matrix (RCTM). Ensured that product development projects and changes to existing products are conducted in compliance with the FDA and EU MDR Quality Regulations.
• Review and approve engineering drawing changes including changes to the Bill of Materials (BOM).
• Involve in performing statistical analysis using statistical software tools (Minitab, Stat Graphics, Statistic).

Key Achievements

• Responsible for receiving first MDR certificate.
• Successfully completed BSI certification and renewal project.
• Responsible for creating and maintaining design history files.
• Received special mention for executing and delivering projects with speed and precision.

• Played a key Quality Team Member in various design & development projects, and ensured that compliance is maintained by meeting functional specifications and user requirements.
• Supported the development and change process of new, sustaining and continuing product development to ensure compliance to processes when making changes to the product (components or system level device changes).
• Designed and executed Design of Experiment (DoE) & Engineering Test Reports to establish validated test methods and inspection system.
• Contributing member to: Design Control, Design Verification and Validation, FDA 510(k) submission activities and 483 Remediation, Gap Analysis, Equipment Validations, Defect Tracking and Risk Assessments.
• Involved in continuous improvement initiatives in Quality Management System (QMS) such as design verification sampling plans, risk management and operator self-inspection.
• Involved in design control process and performed design verification and validation for medical device global expansion projects.
• Performed risk evaluation and executed risk management activities for assigned new product development and validation projects.
• Created and executed design verification and validation test protocols and reports.
• Reviewed and identified gaps in TMV protocols and reports for remediation/revalidation. Remediated the TMV's for identified gaps. Responsible for assisting in creation and approvals of Validation Master Plan (VMP).
• Experienced in in statistical data analysis using Minitab (Gage R&R, Anova studies). Led the qualification/approval of contract manufacturers and OEMs; updated the supplier quality agreements.
• Conducted Design History Files (DHF) gap assessments (audit) and updated the content to satisfy the local SOPs, FDA, ISO 13485, and corporate quality system.
• Evaluated and authored design and process FMEAs, customer complaints, Risk Management Plans/Reports based on ISO 14971 Guidance, including Product Hazard Analysis (PHA).
• Managed projects within Released Systems Engineering, ranging from replacing components, selecting alternate suppliers to remediation and manufacturing site transfer projects using the DMAIC methodology.
• Provided on-going aseptic clean room floor support for all biologic processes and aseptic machining validations for assigned product lines. Supported/reviewed validation deliverables for implementation of various software validations
• Lead in development and execute Test Method Validations (TMVs), develop, execute & writing, review and approve Validation protocols (IQ, OQ, and PQ) and reports.
• Trained personnel on manufacturing instructions, standard operating procedures and good manufacturing practices.

Key achievements

• Managed site specific projects/programs and assisting in providing an infrastructure that allows optimization of business benefit, timing, utilization of resources, and cost. Partnering cross-functional resources to deliver project objectives to the satisfaction of all stakeholders.

• Responsible for product line transfer activities.
• Worked with site quality and management teams to support projects meet Quality Systems, Quality Assurance and Regulatory Compliance as defined by Quality Leadership. Ensured these projects are in compliance with GMP, QSR (including Design Controls), ISO or other applicable requirements.
• Conducted root cause analysis, recommended action items, implemented changes, and conducted verification testing relating to Corrective Action Preventive Action (CAPA) issues.
• Responsible for conducting process validation of hydrophilic and parylene coating machines.
• Worked with Sr. Manufacturing Engineer to complete the project within the deadline, provided technical support to the product builders in UV bonding process.
• Assisted Equipment Engineer during the Maintenance activities.
• Participated in daily yield meetings which emphasize on the PFMEA, daily CAL/PM activities, 5S, lean Methodologies.
• Performed engineering tests to reduce the scrap rate and increase the daily yield.
• Created and coordinated efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR compliance .