IT Software Quality Engineer

Ivemsa; Mexicali; Presencial; MXN 1,079,000 - 1,619,000; Jornada completa

Descripción de la vacante

A leading company in medical technology in Mexicali is looking for an experienced professional to lead software quality engineering activities. You will ensure compliance with ISO 13485 and FDA regulations while developing software quality documentation. The ideal candidate has a Bachelor's degree in Engineering, over 5 years of experience in the medical device industry, and strong knowledge of global regulatory frameworks. This position is crucial for driving quality standards throughout the product lifecycle.

Formación

• 5+ years of experience in Quality, Regulatory, or Compliance roles in the medical device, diagnostics, or life sciences industry.
• Strong understanding of global regulatory frameworks (FDA QSR, ISO 13485, EU MDR).
• Experience with IEC 62304 (Medical Device Software – Software Life Cycle Processes).

Responsabilidades

• Lead software quality engineering activities ensuring compliance with industry standards.
• Develop and approve software quality documentation including validation and risk management.
• Drive software-related risk management activities and lead investigations for corrective actions.

Conocimientos

Software verification and validation

Root-cause analysis

Data analytics

Problem-solving

Educación

Bachelor’s degree in Software Engineering, Electronic Engineering, or Biomedical Engineering

Descripción del empleo

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).