Software Quality Engineer

Engineer, Software QualityLocation: Pleasanton, CAWork Arrangement: 100% OnsiteDuration: Contract – 12 MonthsPotential: Possibility of conversion to permanentBusiness Unit: Heart FailureHours: Monday–Friday, 8:00 AM–5:00 PMPosition OverviewWe are seeking an Engineer, Software Quality to support software quality, compliance, verification and validation, risk management, and continuous improvement activities within a regulated medical device environment. This role will work closely with Software Engineering, Systems Engineering, Quality, Regulatory, Cybersecurity, and other cross-functional teams to ensure software and system development activities meet applicable quality and regulatory requirements. The ideal candidate will have a strong quality and process-oriented background with an understanding of software development and validation, rather than a heavy software testing or test automation background.Key ResponsibilitiesSupport software verification and validation (V&V) activities, including development and review of test protocols, plans, reports, and related quality documentation.Support assessments of non-product software and associated quality requirements.Support product cybersecurity assessments in collaboration with cross-functional teams.Review software and system documentation to ensure quality, consistency, and regulatory compliance.Maintain requirements traceability and support software development lifecycle (SDLC) processes.Perform and support risk assessments, including FMEA and hazard analysis.Identify quality issues, facilitate root-cause analysis, and support timely issue resolution.Participate in sustaining engineering activities, including post-release support and issue resolution.Participate in design reviews and represent Quality during applicable review and approval activities.Support post-release software changes and ensure appropriate quality and compliance processes are followed.Support internal and external audits, including audit readiness and response activities.Identify and support quality system and process improvements.Collaborate with cross-functional teams to ensure compliance with applicable FDA and industry requirements.Contribute to continuous improvement of software quality processes, documentation, and controls.Required QualificationsBachelor's degree in Computer Science, Software Engineering, Systems Engineering, or a related technical field.Minimum 2 years of experience in software quality, software validation, systems engineering, quality engineering, or a related discipline.Experience working within a regulated industry, preferably medical devices, diagnostics, pharmaceutical, or another highly regulated environment.Understanding of software quality and software verification and validation processes.Experience with requirements traceability and software development lifecycle processes.Knowledge of risk management, including FMEA and/or hazard analysis.Strong understanding of quality and compliance principles.Strong analytical, problem-solving, written, and verbal communication skills.Ability to work independently with minimal supervision while collaborating effectively with cross-functional teams.Preferred QualificationsExperience in a medical device environment.Knowledge of FDA regulations and quality requirements.Experience with ISO 13485.Experience with IEC 62304.Experience supporting quality or regulatory audits.Experience with CAPA, nonconformance, deviation, or issue-resolution processes.Experience with process improvement and quality system improvement initiatives.Familiarity with software cybersecurity quality requirements.The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.