IT Software Quality Engineer

hace 4 días


Mexicali, México Ivemsa A tiempo completo

Responsibilities Lead software quality engineering activities across the full product lifecycle, ensuring compliance with ISO 13485, FDA QSRs, IEC 62304, ISO 14971, and relevant cybersecurity and data‑protection requirements. Develop, review, and approve software quality documentation, including validation plans, protocols, reports, requirements traceability, verification/validation evidence, and risk‑management documentation. Drive software‑related risk management activities, including identification of hazards, evaluation of risk mitigations, and verification of risk control effectiveness. Lead complex investigations using advanced root‑cause analysis, data analytics, and statistical methods to identify systemic trends, prevent recurrence, and drive corrective and preventive actions (CAPA). Partner closely with global Software Engineering, Systems Engineering, Product Security, Regulatory, and Clinical teams to ensure alignment around software development, V&V expectations, and Quality System. Requirements Lead and support software verification and validation activities, including test‑method development, test strategy definition, automation opportunities, and readiness assessments for release. Analyze software defect data, process metrics, and nonconformance trends to identify improvement opportunities and implement preventive measures. Ensure proper execution of software change‑control processes, confirming changes are validated, documented, and compliant before release. Validate software tools, automated test platforms, and data systems in accordance with Quality System and regulatory requirements. Provide technical guidance and mentorship to engineers and technicians across the Quality organization, strengthening skills in software quality, documentation practices, and problem‑solving. 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). #J-18808-Ljbffr



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