Emily Nicholson
About Emily Nicholson
Emily Nicholson is the Post Market Surveillance Lead at ATCC, with extensive experience in quality assurance and regulatory compliance in the medical technology field. She has held various roles at Thermo Fisher Scientific and Valley Health, and she holds multiple degrees in healthcare and medical technology.
Current Role at ATCC
Emily Nicholson serves as the Post Market Surveillance Lead at ATCC, a position she has held since 2023. In this role, she is responsible for overseeing post-market surveillance activities, ensuring compliance with relevant regulations, and managing data related to product performance. Her work is conducted in a hybrid environment based in Manassas, Virginia.
Previous Experience at Thermo Fisher Scientific
Emily Nicholson has extensive experience at Thermo Fisher Scientific, where she held multiple roles from 2016 to 2022. She began as a Quality Specialist III, advancing to Quality Assurance Team Lead and later Quality Assurance Supervisor. During her tenure, she coordinated site Regulatory Field Action/Recall activities, managed the IVD Internal Auditing Program, and supervised external inspections, including FDA audits.
Educational Background
Emily Nicholson has a solid educational foundation in healthcare and medical technology. She earned an Associate's degree in Pre-Physical Therapy and Medical Technology from WVU Potomac State College from 2004 to 2006. She later obtained a Bachelor of Science in Medical Technology from West Virginia University School of Medicine in 2008 and a Master of Healthcare Administration from Walden University from 2012 to 2014.
Expertise in Quality Assurance and Compliance
Emily Nicholson is well-versed in quality assurance and compliance within the healthcare sector. She has experience in data mining from SAP and Master Control Databases, and she has developed quality policies to comply with standards such as 21 CFR 820, ISO 13485, and MDSAP. She holds an IVDR Auditor Certificate and has led efforts to achieve compliance with the In Vitro Diagnostic Regulation (IVDR).
Professional Contributions and Initiatives
Throughout her career, Emily Nicholson has contributed to various quality assurance initiatives. She has managed and coordinated multiple recall events, including one Class 2 and three Class 1 recalls. Additionally, she has developed customer relationships at Fisher Diagnostics, serving as the primary contact for issue resolution and enhancing customer satisfaction.