IT Software Quality Engineer
Ivemsa
Bachelor’s degree is required in Software Engineering, Electronic Engineering or Biomedical Engineering. 5+ years of experience in Quality, Regulatory, or Compliance roles within the medical device, diagnostics, or life sciences industry. Demonstrated success in regulatory authority interactions and external audits (FDA, ISO, EU MDR, or equivalent). Strong understanding of global regulatory frameworks (FDA QSR, ISO 13485, EU MDR, MDSAP). Experience with IEC 62304 (Medical Device Software – Software Life Cycle Processes.
Enero 22 2026 en Mexicali