Senior MedTech Software Quality Engineer (ISO 13485 & FDA)

A leading medical technology company in Mexicali, Baja California, is seeking a Lead Software Quality Engineer to oversee quality engineering activities throughout the product lifecycle. The role involves developing quality documentation, managing risks, and supporting new product introductions. Ideal candidates have a Bachelor’s degree and over 5 years of experience in Quality or Regulatory roles, along with a strong understanding of regulatory frameworks like ISO 13485 and FDA QSR. Excellent communication skills and technical guidance abilities are also essential.
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