Expert in manufacturing quality management with extensive experience in driving compliance and quality assurance initiatives. Proven success in leading cross-functional teams, developing quality metrics, and implementing processes that significantly improve product outcomes and operational efficiency.
Overview
15
15
years of professional experience
Work History
Quality Manager – Medical Device / Combination Products (MDCP)
Pfizer inc.
Rocky Mount, North Carolina
04.2025 - 02.2026
Led quality assurance initiatives to ensure compliance with regulatory standards.
Developed and implemented compliant CAPA and quality management review standards.
Developed and validated functional test methods for prefilled syringe characterization and release testing, ensuring product conformance.
Led root cause analysis for non-conformance incidents in manufacturing processes.
Developed key performance indicators to measure process efficiency and quality standards. related to process performance metrics such as defect rate, scrap rate.
Collaborated with cross-functional teams in the development of new products and processes to ensure high levels of quality are maintained throughout the design phase and to resolve quality-related issues.
Trained staff on quality assurance protocols and best practices.
Senior Quality Engineer – MDCP
Pfizer inc.
Rocky Mount, NC
08.2022 - 04.2025
Maintained Design History File and conducted post-market surveillance activities to ensure compliance and product safety.
Implemented statistical process control methods in order to monitor production processes for variations.
Established and monitored key performance indicators (KPIs) for quality objectives.
Developed Key Performance Indicators for measuring overall performance of the Quality Assurance Department.
Coordinated cross-functional teams to enhance product quality and performance, leading to improved stakeholder satisfaction.
Analyzed quality metrics and data to identify trends and areas for improvement, informing strategic decisions for quality enhancement.
Demonstrated strong knowledge of company standards and protocols during inspections.
Coordinated cross-functional teams to enhance project communication and collaboration.
Led team meetings to discuss project progress and address any challenges encountered.
Monitored project progress and provided updates to stakeholders.
Quality Ops Laboratory Associate
Pfizer inc.
Kalamazoo, MI
10.2015 - 02.2019
Calibrated instruments to ensure accuracy of readings and measurements taken during experiments.
Conducted routine laboratory tests following standard operating procedures.
Collaborated with team members to troubleshoot technical issues.
Associate Scientist - QC Tech Svcs
Perrigo co.
Allegan, Michigan
01.2014 - 10.2015
Developed and validated analytical test methods for raw materials and finished products, ensuring compliance with regulatory standards and supporting product quality assurance.
Analyzed data and documented findings in technical reports for review.
Achieved project milestones on schedule while managing multiple projects at once.
QC Laboratory Technician
Perrigo co.
Allegan, Michigan
10.2010 - 01.2014
Reviewed and validated analytical data to confirm adherence to specifications.
Documented test results and maintained regulatory-compliant records for traceability.
Conducted routine testing of raw materials to ensure quality standards were met.
Education
Bachelor of Science - Biomedical Sciences / Chemistry
Western Michigan University
Kalamazoo, MI
06-2010
Skills
Regulatory compliance
CAPA management
Design control
Supplier management
Test method development
Quality management
Data measurement, analysis and improvement
Adverse event and advisory notices reporting
Production controls
Root cause analysis
Audit readiness
SOP management
Risk management
Cross-functional team leadership
Courses
AAMI – The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485:2016 Navigating Regulatory Requirements
AAMI – Integrating Risk Management into the Product Life Cycle