Open to opportunities

Lisa Wengel

@lisawengel

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Experienced regulatory affairs professional with a focus on quality systems.

United States

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What I'm looking for

I am looking for a role that fosters collaboration, innovation, and professional growth in regulatory affairs.

I am a resourceful and principled Regulatory Affairs and Quality Systems professional with over 10 years of experience in FDA- and ISO-regulated environments. My expertise spans the medical device, pharmaceutical, and biotech industries, where I have developed a strong foundation in regulatory compliance, CAPA system management, and Quality Management System (QMS) development.

Throughout my career, I have successfully led cross-functional project management initiatives and have been recognized for my integrity and collaborative approach. My recent project involved developing a comprehensive market entry regulatory strategy for Artificial Intelligence-guided Software as a Medical Device (SaMD) in key European markets, showcasing my ability to adapt and add value to any team.

Experience

Work history, roles, and key accomplishments

Quality Assurance Analyst

Agilent Technologies, Inc.

Jul 2022 - Present (3 years 1 month)

Ensured adherence to FDA (21 CFR Part 820), EU MDR, and ISO 13485 standards across site operations. Managed site-wide training programs and facilitated the CAPA system, exercising root cause analysis and risk management.

FDA EU MDR ISO 13485 Audit Management Document Control CAPA Training Risk Management

Quality Systems Specialist / CAPA Coordinator

Northern Digital, Inc. (NDI)

Sep 2021 - Present (3 years 11 months)

Conducted comprehensive internal audits and supported Notified Body and other third-party inspections. Served as Subject Matter Expert (SME) in CAPA lifecycle for North American operations, from investigation to corrective and preventive action implementation.

Internal Audit CAPA Technical Writing Cross Functional Collaboration Root Cause Analysis Continuous Improvement

QA/QC Microbiology Technical Writer

EDGE Pharma, LLC

May 2020 - Present (5 years 3 months)

Composed SOPs, protocols, and version-controlled documents; executed environmental excursion and laboratory investigations, deviations, and CAPA. Reviewed and approved microbiological data, ensuring cGMP/FDA regulatory compliance.

Technical Documentation Data Integrity Project Management SOP流程设计 FDA Compliance Laboratory Investigations CAPA

QC Microbiology Manager

EDGE Pharma, LLC

Aug 2019 - Present (6 years)

Supervised microbiology staff, test procedures, programs, and daily operations. Led the site through FDA and state inspections with successful outcomes.

Staff Supervision data recovery

QC Microbiologist / Analyst

EDGE Pharma, LLC

Nov 2018 - Present (6 years 9 months)

Conducted sterility testing, bioburden, and endotoxin assays. Performed routine environmental monitoring, enumeration, and microbial identification.

Training Development CAPA SOP流程设计

Research & Development Technician

Autumn Harp, Inc.

Mar 2016 - Present (9 years 5 months)

Executed OTC product evaluations under USP and internal protocols. Created documentation for test methods, product specifications, and non-conformance reports.

Stability Testing Technical Writing Continuous Improvement

QA/QC Microbiology Technician

Keurig Green Mountain, Inc.

Apr 2015 - Present (10 years 4 months)

Facilitated high-volume sampling in laboratory space, performed enumeration, bioburden, coliform testing, and environmental monitoring. Developed internal procedures (SOP) and managed calibration, data recovery, and OOS documentation.

Document Control SOP Development Calibration Documentation data recovery OOS Documentation

QA/QC Laboratory Technician

Keurig Green Mountain, Inc.

Nov 2014 - Present (10 years 9 months)

Conducted pH, brix, acid titration, turbidity, and HPLC analyses. Managed SAP product release, CoA, quality reports, and sensory panels.

Data Evaluation SOP Development SAP Product Release

QA/QC Laboratory Technician

Agri-Mark / Cabot Creamery Cooperative, Inc.

Mar 2014 - Present (11 years 5 months)

Performed pH, butterfat, titration, and solids analysis. Supported yeast/mold tracking and chemical oxygen demand testing.

Quality Testing PH Analysis Butterfat Analysis Titration Solids Analysis Yeast Mold Tracking Chemical Oxygen Demand Testing

Education

Degrees, certifications, and relevant coursework

Northeastern University

Master of Science, Regulatory Affairs

Activities and societies: Experiential Network (XN) Learning Project: Regulatory Optimization and Market Acceleration

Currently pursuing a Master of Science in Regulatory Affairs. Completed an Experiential Network (XN) project focused on developing a comprehensive market entry regulatory strategy for Artificial Intelligence-guided Software as a Medical Device (SaMD) in key European markets.