Shriram (Ram) Srinivasa is a Quality Compliance Consultant at Alvamed. Ram has more than 8 years of experience in Quality Systems, Quality Engineering and Design Assurance. He has a strong background in electromechanical devices, having worked with Class II and Class III cardiovascular catheters, disposables, stents and drug-device combination products. He is a Six Sigma black belt with expertise in design controls, Gamma and EtO sterilization, risk management, supplier management, design transfer, statistics and postmarket surveillance.
Ram’s accomplishments include the following:
- Supported QMS activities for multiple small clients that had limited resources and expertise. Activities included conducting internal and supplier audits, maintaining NCRs, CAPAs, IAFs and change control process. Established a QMS tracker matrix to help regularly review and maintain different aspects of the QMS system. Prepared annual Management Reviews to measure the effectiveness of the QMS.
- Managed complaint handling process, including Process Timelines, Technical Complaint Review, Metric Reporting and Complaints Trends Analysis to senior management.
- Revamped and improved process procedures around Supplier Management, Risk Management, UDI, Labeling, Recalls, Test Method Validation and Process Validation.
- Challenged with minimal support and short timelines, Ram came up with a streamlined and systematic approach for harmonizing and restoring their Risk Management process and Risk management files for multiple clients. This process included a detailed gap assessment and list of findings, proposal to address these findings and updates to the Risk Management Files to help prepare the client for upcoming audits and submissions.
- Identified and planned design verification activities for drug container, including biocompatibility, container closure integrity, packaging and extractables testing.
- Led Design of Experiments project identifying key parameters for a critical test method; supported and created test method validation documentation for various DV test methods.
- Conducted design transfer activities with contract manufacturer and engineering and successfully qualified first commercial line.
- Supported IEC 60601 testing and completion of various checklists for multiple electromechanical devices for EU and FDA submissions.
- Established SME for all sterilization processes, including EtO and Gamma Irradiation validation and routine monitoring, endotoxin, bioburden, sterility and EtO residuals testing.
- Collaborated with a cross-functional team to perform supplier part qualifications for new components and identify CTQ dimensional and visual criteria for First Article Inspections.
Ram holds a bachelor’s degree and a master’s degree, both in Biomedical Engineering, from the University of Michigan.
