Senior Software Quality Engineer

• Base Pay $ - $ / Year
• Job Category Computer Science, Engineering
• Industry Manfuacturing, Regulations
• Employee Type Exempt Full Time
• Required Degree 4 Year Degree
• Travel 10%

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.

This role operates within a layered regulatory framework:

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…