Alexandra Ciolko

Background

About Alexandra Ciolko

I am a problem solver in the diagnostics space, with over seven years of experience in managing and supporting the research and development of in vitro diagnostic (IVD) and pharmaceutical quality control (QC) systems. My mission is to lead cross-functional teams in development and post-launch efforts within the diagnostics space while ensuring compliance with design control standards and regulatory requirements. I also hold a Master's Degree in Biomedical Engineering, with a focus on orthopedic biomaterials and corrosion.My core competencies include strategic thinking, risk management, quality system management, data analysis, technical writing, and communication. I have successfully driven programs to support new product development for assays at rapidly growing diagnostics companies, such as bioMérieux and BioFire, delivering innovative solutions that meet customer needs and market demands. As a natural leader and mentor, I have also fostered the professional growth of program teams, enabling them to take on complex and challenging projects with confidence. In my free time, I enjoy biking, running, and hiking in the mountains of Colorado with my pup!