Experience

Formerly Meridian Medical Technologies | KDD

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Validation Quality Engineer I

  • Jun 2021 - Present

  Responsible for developing and executing validations to ensure regulatory compliance to internal and external standards for combination drug/ medical device auto-injectors in aseptic manufacturing. - Developed and executed comprehensive validation protocols, including equipment qualifications, cleaning validations, and mixing homogeneity studies. - Managed critical equipment requalification results and coordinated cross-departmental testing. - Authored master validation plans and executed temperature mapping studies to ensured compliance with strict temperature requirements. - Led data integrity evaluations and collaborated on equipment functionality and audit trail reviews. - Conducted different sampling tasks, such as visual inspections, bioburden and endotoxin sampling, residual sampling, and collecting TOC samples. Also, served as a media fill quality observer and qualified for clean room gowning. Show less



BD

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Manufacturing Quality Engineer

  • Sep 2019 - Jun 2021

  Responsible for the process optimization, validations, root cause analysis (CAPA), product dispositions (MRBs), product non-conformances (QNs), graphic approvals, and MSA (Measurement System Analyses) for medical device operations. Ensure all systems are functioning at optimized levels while meeting quality standards. ➥Lead multiple line improve and validation projects. ➥Completed validation of new critical stopper component functionality and the viability of the new component on the saline filled syringe line. Enabling options to use multiple supplier components to optimize cost and business continuity. ➥Developed and implemented new product qualification protocols (Operational and Performance Qualifications) on injection molding presses. On time completion of molding qualification ensured line validation and new product launch stayed on track. ➥Worked as part of a cross functional team to validate 3 lines for a large client to meet higher FDA quality standards. ➥Responsible for fostering engagement of a cross functional team in QC process. Lead of Behavioral Based Quality (BBQ) team to conduct a dialog between teams to promote a better understanding of their roles and importance to the process. ➥Oversee a quality near-miss program to that has identified 23 quality near miss YTD and resolves potential issues before they develop into larger problems. ➥Implemented training, rotating audits, and quality communication alerts resulting in a 78% decrease in environmental failures in a clean room environment. Show less



Accuray, Inc.

• Madison, WI

• Product Surveillance Specialist

  • 2019 - 2019

  At this position I was charged with the professional and timely resolution of customer complaints for a medical device company creating cancer radiation equipment. Championed exceptional communication and customer service. ➥Collaborate on a team of 5 to label, investigate, process, and track resolutions of complaints. ➥Fielded up to 40 complaints daily. Maintained detailed documentation on damages, medical details, or software failings. Sent documentation to engineer for escalation as necessary. ➥Ensured compliance with all applicable reporting regulations. Show less



Senior Project

• Student, BSc of Biomedical Engineering

  • Aug 2015 - May 2016

  I designed and constructed a hand-held fine motor skills assistance device for Parkinson’s patients suffering tremors. Presented as a Capstone Project. Used a fused sensor to detect multiple degrees of freedom and a signal processor for a countermotion actuation signal to a motor unit. I designed and constructed a hand-held fine motor skills assistance device for Parkinson’s patients suffering tremors. Presented as a Capstone Project. Used a fused sensor to detect multiple degrees of freedom and a signal processor for a countermotion actuation signal to a motor unit.



Lauras International

• Australia
• Business Consulting and Services
• 1 - 100 Employee

• Process Engineering Intern

  • 2014 - 2016

  I interned three consecutive summers for a consulting firm supporting CPG and pharmaceutical clients. Analyzed and adjusted work flows to ensure process accuracy and efficiency. ➥Delivered a 15% output improvement through strategies designed to streamline processes and reduce cycle time for a frozen food factory. Results included $2M in annual savings. ➥Implemented strategies to increase product volume to match client’s growing demand in the food service industry, increasing output by 20%. ➥Developed labor optimization strategies and training materials leading to a 40% reduction in changeover rates. ➥Implemented a new expense system for a more efficient and accurate billing process requiring 75% less time with a 99% accuracy rate. ➥Worked with clients such as Starbucks, Walmart, and CSM Bakeries. Show less