Elisabeth Cody
Hunt Valley
Summary
Experienced Quality Engineer with over 6 years in FDA-regulated manufacturing. Expertise in validation, CAPA, root cause analysis, and quality system compliance. Proven ability to enhance production quality and audit readiness while driving cross-functional process improvements. Leverages foresight and forecasting techniques to optimize design and manufacturing processes.
Overview
8
8
years of professional experience
Work History
Quality Engineer I
Becton Dickinson (BD)
Hunt Valley
01.2024 - Current
- Develop and execute validation protocols (IQ/OQ/PQ) for sterilization and laboratory equipment
- Led complaint investigations and performed root cause analysis, resolving product and process issues affecting quality and compliance
- Analyze complaint trends and partner with cross-functional teams to implement CAPAs reducing recurring issues
- Supported manufacturing and engineering teams in enhancing process performance and ensuring product quality
- Participated in internal and external audits, facilitating documentation, risk assessments, and change control activities
QM Associate Scientist
Becton Dickinson
01.2021 - 01.2024
- Conducted microbiological testing and product evaluations ensuring compliance with GLP/GMP standards
- Supported validation documentation and audit preparation to facilitate regulatory compliance
- Compiled and analyzed quality data for post-market surveillance and management review
- Supported CAPA investigations and non-conformance resolution efforts
Laboratory QA Technician
Dairy Maid Dairy & Other Roles
01.2018 - 01.2021
- Conducted laboratory testing to ensure compliance with FDA and food safety standards, contributing to product safety and quality
- Prevented $25K in product loss by identifying process deviations prior to release
- Reduced Listeria contamination risk by 40–50% through improved sanitation and swabbing programs
- Trained new staff on QA procedures and equipment calibration, enhancing team competence in documentation practices
Education
M.S. - Business Analytics
William & Mary
12-2026
B.S. - Environmental Science
Shepherd University
Skills
- Validation (IQ/OQ/PQ)
- GMP compliance
- CAPA & Non-Conformance
- Root Cause Analysis
- Audit Support
- Risk Management
- Process Improvement
- FMEA (PFMEA familiarity)
- Data analysis
- Documentation Control
- Cross-Functional Collaboration
Websites
Timeline
Quality Engineer I
Becton Dickinson (BD)
01.2024 - Current
QM Associate Scientist
Becton Dickinson
01.2021 - 01.2024
Laboratory QA Technician
Dairy Maid Dairy & Other Roles
01.2018 - 01.2021
M.S. - Business Analytics
William & Mary
B.S. - Environmental Science
Shepherd University