Senior Quality & Validation Engineer

JAIMINI PATEL

Richmond, Henrico, Virginia ***** 972-***-**** *******@*****.***

SUMMARY

An organized and detail-oriented professional with extensive experience in product improvement, project management, risk management, and regulatory compliance. Proven experƟse in quality assurance, technical support, audiƟng, and supply chain management, with a strong background in FDA and ISO regulaƟons. Skilled in data analysis and management and design and change control. Adept at driving successful product improvement iniƟaƟves through well-structured experiments, validaƟon, and verificaƟon processes. Highly experienced in CAPA projects, root cause analysis, and correcƟve acƟons. A dedicated team player and key contributor to the long-term success and growth of the organizaƟon.

FDA and ISO RegulaƟons Medical Technology Compliance and Audits Data Analysis Project Management Quality & Regulatory Compliance Design and Change Control Supply Chain Support Risk Management EXPERIENCE

ABBOTT LABORATORIES, Richmond, Virginia

Senior Quality System and ValidaƟon Engineer, Feb, 2020-2025

Led equipment validaƟons and spreadsheet verificaƟon, ensuring compliance with quality standards and facilitaƟng seamless quality and regulatory approvals.

Conducted monthly Gemba walks in laboratory areas, idenƟfying process improvements that enhanced operaƟonal efficiency.

Processed 50+ document change requests, nonconformance reports, and CAPA acƟviƟes in the Agile electronic system, improving response Ɵmes and ensuring Ɵmely resoluƟon.

Collaborated with cross-funcƟonal teams to address recurring operaƟonal issues, using root cause analysis and problem- solving techniques.

IniƟated meeƟngs to provide updates on ongoing quality indicators, address concerns, and share relevant informaƟon with leaders.

Provided subject maƩer experƟse during CAP, CLIA, quality, and regulatory audits, contribuƟng to successful outcomes with no criƟcal findings.

Maintained a robust quality system, ensuring ongoing compliance during internal and external audits. ABBOTT LABORATORIES, Santa Clara, California

Senior ScienƟst Technical Service, July, 2017-Feb, 2020

Adhered to quality system in accordance with FDA 21 CFR 820, 21 CFR Part 11, and ISO 13485 regulaƟons for class II medical devices for on-market hematology reagent products compliance.

Managed site validaƟon acƟviƟes and represented site on validaƟon process community, providing training on validaƟon procedures per quality system.

Led technical projects for product manufacturing at third-party supplier sites, ensuring alignment with client specificaƟons and quality standards.

Partnered with field service team, quality, supply chain, regulatory, design, and risk management groups for conƟnuous product improvement, facilitaƟng compleƟon of assignments and meeƟng business strategy.

ParƟcipated in cross-funcƟonal teams to resolve on-market product issues, root cause, and complaint invesƟgaƟon, uƟlizing Six Sigma, DMAIC, and CAPA tools and documenƟng in TrackWise system.

Managed internal and external audits as the technical subject maƩer expert, collaboraƟng with auditors to ensure successful compleƟon of regulated audits.

Provided technical oversight to support ongoing laboratory tesƟng and data analysis following GxP. Jaimini Patel, Page 2

ABBOTT LABORATORIES, Santa Clara, California

Technical Support ScienƟst, Jun, 2007-July, 2017

Supported complaint invesƟgaƟons, performed product / process root cause invesƟgaƟons, and implemented global correcƟve and prevenƟve acƟons (CAPA), using TrackWise system.

Performed technical evaluaƟon of products, processes, design specificaƟons, and manufacturing specificaƟons to idenƟfy product / process improvements, troubleshoot lab instrument, and update procedures.

Performed validaƟons (facility uƟlity equipment, test method), executed characterizaƟon studies, and wrote protocols / reports.

Managed department budget by creaƟng purchase orders and following up with service vendors.

Followed site procedures, GMP and GLP techniques, and lab safety documents. ADDITIONAL EXPERIENCE

ABBOTT LABORATORIES, Santa Clara, California, Associate ScienƟst, Jun 2002- Jun 2007. Executed design verificaƟon, stability, feasibility, and characterizaƟon studies. Performed validaƟons. InvesƟgated and resolved internal and on-market product non- conformances, uƟlizing Six Sigma tools. Conducted safety-related inspecƟons of laboratory and promoted safe work environment. Coordinated laboratory equipment calibraƟon acƟviƟes. Evaluated quality control within laboratory, using standard laboratory test and measurement controls, maintaining compliance with CLIA, OSHA, and safety and risk management guidelines. ANTECH DIAGNOSTIC, San Jose, California, Medical Technologist, Feb 2002- Aug 2002. Executed and analyzed clinical tests, including urinalysis, hematology, and serology to aid physicians in diagnosing and treaƟng disease. Operated instruments, including Clinitek 200X and Cell-Dyn 3500 hematology instrument. Ensured test-result validity before recording and reporƟng results in Ɵmely manner. ABBOTT LABORATORIES, Santa Clara, California, Manufacturing Prep Technician, Feb 2001- Aug 2001. Led mulƟple products in ISO Class II and Class III clean room environment. Operated hematology laboratory instruments, including Cell-Dyn series, pH meter, osmometer, conducƟvity meter, spectrophotometer, microscopes, pipeƩes, and scales to support CD reagent, calibrator, controls QC, and micro tesƟng. Demonstrated understanding of quality policy by following established department and standard operaƟng procedures, DOPs, and SOPs.

EDUCATION

THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, Dallas, Texas, Bachelor degree, Medical Technologist DALLAS COMMUNITY COLLEGE DISTRICT, Dallas, Texas, Associate degree, Arts and Science CERTIFICATIONS

CPR and First Aid CerƟfied, 2024

CerƟfied Scrum Master, 2018

Languages: GujaraƟ and Hindi

LICENSURE

ASCP / CLS License, 2006

TECHNICAL SKILLS

MicrosoŌ Office Suite SharePoint Good laboratory PracƟce (GLP) Good Manufacturing PracƟce (GMP) Six Sigma Green Belt Training Brainstorming TroubleshooƟng Data Analysis Problem Solving

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