Dibya Dangi

Lead quality control and assurance process of the company's medical device manufacturing.

• Responsible for monitoring and investigating non-conformances, deviations, customer complaints, and coordinating CAPAs.
• Manage laboratory, ensuring compliance with ISO and other internal requirements.
• Update control charts, identify variations, and present trending data and summary.
• Participate in audits and investigations as required.

Part of a dynamic, fast-paced, and innovative team responsible for supporting manufacturing activities, ensuring adherence to regulatory standards, maintaining high-quality testing protocols for incoming materials and final product, and driving continuous improvement initiatives.

• Monitored and evaluated quality metrics and performance indicators to identify areas for improvement.
• Coordinated with other departments to resolve quality-related issues and implement corrective actions.
• Conducted audits and inspections to assess practices, procedures, and documentation to assure quality operations.
• Prepare reports by collecting, analyzing, and summarizing data, making recommendations, and improvements.
• Initiated change order, collaborated to identify root cause of the failure, and develop corrective action and preventive action.
• Collaborated with project management, process scientists, and suppliers for qualification and validation of raw materials/chemicals and issued SCARs as needed.
• Chaired Material Review board for review and disposition of non-conforming products.

• Responsible for ensuring quality product testing to ISO standards and providing cross-functional assistance with engineering, analytical, and quality control.
• Elemental analysis (using XRF, C/S/O/N analyzer, and ICP-OES) and material characterization (using XRD, SEM/EDS, BET, TGA, DSC) for batch qualification, failure investigation, and contamination analysis
• Provided high-quality, detailed analytical reports to internal and external customers.
• Assumed leadership in the elemental analysis lab; responsible for maintenance, calibration, and troubleshooting of the instrument; trained new technicians.
• Collaborated with development engineers to conduct testing protocols for their analyses.
• Validated new equipment; wrote/modified SOPs, and optimized methodologies.

• Planned, organized, and conducted highly independent research work upon approval of the principal investigator while maintaining the smooth operation of the laboratory
• Experienced in water purification technologies, catalysis, gas filtration membranes/ sensors, and polymers
• Calibrated, repaired, and set up laboratory equipment
• Adapted procedures and methods relative to change in research projects
• Conducted experiments, collected data, analyzed, summarized, organized, and prepared scientific reports
• Demonstrated ability to work and communicate with other researchers and support staffs in a cross functional setting
• Contributed to health and safety committee and chemical waste disposal team
• Designed tests, evaluated methods and protocols and related safety measures