Led and contributed to quality and regulatory projects throughout the full lifecycle of the medical device manufacturing process. Collaborated effectively with cross-functional teams on large-scale client projects, providing both guidance and leadership to drive successful outcomes and deliverables. Developed specialized expertise in key quality and regulatory areas, including:• Quality Management System (QMS) Development, Implementation, & Remediation• Design Assurance/Design Controls• Product Realization• EU MDR/IVDR Remediation• Technical Documentation Review/Remediation• Corrective and Preventive Action (CAPA) Management• Risk Management• Inspection Readiness & Audit Defense Strategies• Regulatory Submissions (US & OUS)• Post-Market Surveillance (PMS)

Worked to optimize the function and quality of a variety of medical device systems within a GMP-regulated manufacturing facility. Some of my responsibilities included:• Continuous process improvement• Investigation of non-conforming product to determine the root-cause of the issue • Made changes/updates to controlled documents via red lining or engineering change requests• Developed and updated SOPs and other work/testing instructions• Assisted with Internal GMP auditing• Provided oversight into the device history records to ensure data was within specification • Ensured proper testing procedures were being followed correctly• Assisted with the review of validation protocols and reports • Responded to customer complaints, CAPAs, & SCARs (Post-market surveillance)

This was an unpaid capstone project per MSU's College of Engineering where I had the opportunity to practice and implement multiple engineering principals to research, design, & select a new spray nozzle capable of enhancing the efficacy of the cleaning procedure within Perrigo's pharmaceutical manufacturing facility located in Allegan, Michigan. Some of my responsibilities included:• Applied engineering principals associated with fluid mechanics, the environment, heat transfer, biology, medicine, statistics, & dynamics• Developed a cost analysis for the design, outlining projected savings in time, labor, & water usage• Developed a risk assessment to evaluate the safety of the spray nozzle and its cleaning effectiveness • Created a drawing of the selected design using AutoCAD• Participated in on-site testing of the nozzle • Drafted technical reports and gave thorough presentations Overall, it was a great, yet challenging project experience that transformed our teams' understanding of not only the complex engineering systems, tools, and practices involved within a pharmaceutical facility, but also our understanding of how heavily regulated the industry is so that consumers know they are getting high quality products.