Akshay S.
Quality Assurance Engineer Ii @Thermo Fisher Scientific
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WORK HISTORY
Quality Assurance Engineer Ii @Thermo Fisher Scientific
MD, US
EDUCATION
University of the Cumberlands
Doctor of Philosophy - PhD, Organizational Leadership
Savitribai Phule Pune University
Bachelor of Engineering - BE, Mechanical Engineering
Indiana Institute of Technology
Master of Science - MS, Engineering/Industrial Management
ABOUT AKSHAY S.
I’m a project-driven Quality and Compliance professional with over five years of experience in IVD, RUO, and biologics manufacturing. My focus is on complaint handling, regulatory compliance, and quality systems oversight. I deliver measurable impact through data-driven investigations, CAPA management, and continuous improvement.I have deep expertise in FDA, ISO, IVDR, and other global regulatory frameworks, with hands-on experience in next-generation sequencing, aseptic processing, and solid dose manufacturing. I’ve led cross-functional initiatives, mentored junior team members, and partnered with senior leadership to align quality operations with strategic goals.Currently pursuing a Ph.D. in Leadership, I am focused on bridging operational execution with organizational strategy. My aim is to strengthen how quality systems and project oversight contribute to long-term success. I apply Lean Six Sigma, risk management, and tools like Veeva Vault, TrackWise, SAP, and Agile to streamline workflows, enhance compliance, and improve efficiency.I thrive in fast-paced environments that value precision, accountability, and continuous improvement. I’m always looking to advance the role of quality in life sciences and healthcare.Let’s connect to explore how we can build stronger quality systems and drive regulatory excellence together.
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