Bhargav Pappula
Quality Engineer @Medline Industries Limited
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WORK HISTORY
Quality Engineer @Medline Industries Limited
IL, US
Provide comprehensive quality engineering support for Class implantable medical devices, ensuringfull compliance with FDA 21 CFR Parts 820 & 11, ISO 13485, and cGMP regulations acrossmanufacturing and validation activities.• Lead and execute process validation, equipment qualification, and test method validation (IQ, OQ, PQ,TMV) to maintain a validated and controlled manufacturing environment.• Perform detailed risk-based assessments including PFMEA, hazard analysis, and change impactassessments to evaluate risks associated with process, equipment, and design changes.• Author, review, and approve validation protocols, reports, traceability matrices, SOPs, work instructions,and controlled forms, ensuring data integrity and audit readiness.• Manage change control activities using Agile PLM, coordinating cross-functional reviews and approvalswith Engineering, Manufacturing, R&D, and Quality teams.• Investigate nonconformances, deviations, and validation failures using structured RCA tools such as 5-Why and Fishbone diagrams.• Drive CAPA development and implementation, ensuring corrective actions are effective, sustainable, andaligned with regulatory expectations.• Monitor manufacturing processes using SPC tools, control charts, and capability studies (Cp/Cpk) toassess process stability and detect early trends.• Collaborate with manufacturing teams to implement corrective actions that improve process robustness,yield, and product consistency.• Support internal, customer, and regulatory audits by preparing quality documentation packages andresponding to auditor observations.• Provide quality oversight during equipment installation, process scale-up, and technology transfer,ensuring validation completion prior to production release.• Contribute to continuous improvement initiatives by analyzing quality metrics, identifying gaps, and drivingactions to enhance compliance and operational efficiency.
EDUCATION
Lewis University
Master's degree, Health Information/Medical Records Administration/Administrator
ABOUT BHARGAV PAPPULA
Quality Engineering professional with experience supporting Class II and Class medical devices in regulated manufacturing environments. Skilled in executing process validations, equipment qualifications, and test method validations in compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP standards. Experienced in risk-based quality methodologies including PFMEA, DFMEA, and hazard analysis to evaluate manufacturing and design risks. Proven ability to manage change control processes, support regulatory audits, and drive CAPA initiatives to ensure product quality and compliance. Adept at collaborating with cross-functional teams including Manufacturing, Engineering, R&D, and Supplier Quality to improve process robustness, product reliability, and operational efficiency. Core expertise includes validation lifecycle management (IQ/OQ/PQ), statistical process control (SPC), process capability analysis (Cp/Cpk), root cause investigations, and quality system documentation. Passionate about maintaining compliant manufacturing systems while driving continuous improvement initiatives that enhance product quality and patient safety.
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