Senior Software Quality Engineer

Senior Software Quality Engineer

The Senior Software Quality Engineer serves as a technical quality lead for software-enabled medical device systems, acting as a key interface between software engineering, systems engineering, manufacturing, and external partners.

This role is responsible for leading software quality and validation activities to ensure compliance with Design Controls, Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD) regulatory expectations, and the successful development and commercialization of connected healthcare solutions.

The position contributes to the continuous improvement of software-focused Quality Management System (QMS) processes and ensures that software systems, integrated devices, and data infrastructure are validated, traceable, secure, and compliant across the product lifecycle.

• Core: ISO 13485 (QMS), ISO 14971 (Risk), IEC 62304 (Software)
• Extensions: IEC 62366 (Usability), IEC 81001-5-1 (Cybersecurity)
• Regulatory: QMSR, Software Validation Guidance
• Modern Practice: CSA, GAMP 5

• Support and contribute to the development and continuous improvement of software-specific QMS processes
• Ensure adherence to established processes for Software Development Lifecycle (SDLC), Design Controls, and risk-based validation approaches
• Support configuration, implementation, and use of QMS tools (e.g., EtQ, requirements/test management systems)
• Establish and maintain end-to-end traceability per IEC 62304 and QMSR (User Needs → System Requirements → Software Requirements → Verification → Validation)
• Ensure all requirements are complete, testable, and risk-based and aligned with intended use and clinical workflows
• Support development and maintenance of the Design History File (DHF)
• Lead development and execution of risk‑based software validation strategies for assigned systems or projects
• Develop and execute test protocols, scripts, and reports, regression testing (manual and automated), negative and edge‑case testing
• Ensure defects are documented, classified, investigated, and trended
• Partner with development teams to identify and resolve defects
• Lead validation of assigned system integrations, including device‑to‑software connectivity and data acquisition, processing, and reporting
• Ensure data integrity and accuracy and audit trail / event logging compliance
• Support cybersecurity through risk identification and mitigation activities and integration with ISO 14971 processes
• Support usability and human factors validation (IEC 62366)
• Apply ISO 14971 risk management practices within software development and validation activities
• Ensure risks are identified, documented, and mitigated and linked to requirements and verification activities
• Support management of SOUP (Software of Unknown Provenance) and third‑party and open‑source risks
• Support internal/external audits and regulatory inspections
• Participate in software release readiness activities
• Ensure adherence to configuration management processes and change control procedures
• Support verification that software baselines are controlled, documented, and approved
• Support design transfer to manufacturing and deployment environments
• Ensure validation activities support repeatable and scalable deployment
• Participate in supplier quality and monitoring activities
• Support pilot and deployment activities through real‑world validation and performance monitoring
• Monitor defects, complaints, and system performance trends
• Support post‑market surveillance and continuous improvement efforts
• Collaborate with software, systems, product, clinical, and manufacturing teams
• Provide quality and regulatory input during design reviews
• Support alignment of Agile development practices with Design Control and traceability requirements
• Provide technical guidance and mentorship to less experienced team members
• This role is evaluated for success against metrics such as defect escape rate, traceability completeness, validation cycle time, audit findings, and compliance outcomes.

• Understands internal and external customers
• Assures a safe work environment
• Encourages individual development;…