FDA Investigators 4

Auditor, Principal Consultant at Conscious Consulting Solutions LLC, brings extensive FDA expertise to assist companies in achieving compliance with quality system regulations. With a background as an FDA Investigator and Medical Device Specialist, they conduct mock FDA inspections, remediate FDA observations, and provide training on medical device quality system regulations. Skilled in investigating complaints, recalls, and manufacturing processes, they offer effective communication and adaptability to diverse environments. Holding certifications as an FDA Certified Medical Device Investigator and ISO 13485 Lead Auditor, along with a Master's degree in Mechanical Engineering from San Jose State University, they are available for assignments both domestically and internationally.