IT Software Quality Engineer

·       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.