IT Software Quality Engineer

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).