Software Quality Assurance Engineer
Company Description SARACA is a global engineering R&D services company supporting 25+ Fortune 500 customers across MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm industries. The company is ISO 13485 certified and has extensive experience in designing and developing innovative medical devices, including embedded software, UI/UX, mechanical systems, and product testing. SARACA has unique expertise in IEC 62304, EU MDR, and scientific and regulatory documentation for MedTech. With a team of 400+ engineers and management consultants, the organization delivers complex product engineering solutions through onsite and offsite models worldwide. SARACA promotes an inclusive, innovation-driven work culture and focuses on helping customers grow faster and lead their industries.Role Description This is a contract, on-site Software Quality Assurance Engineer role based in Hercules, CA. The Software Quality Assurance Engineer will plan, design, and execute manual test cases for software applications, focusing on verification and validation activities aligned with regulatory and quality standards. Responsibilities include reviewing requirements and design documents for testability, identifying defects, documenting issues clearly, and collaborating closely with software development and product teams to resolve them. The role also involves contributing to test plans, test reports, traceability matrices, and other quality documentation, as well as supporting audits, inspections, and continuous improvement initiatives in the software quality lifecycle. The engineer will work with cross-functional stakeholders to ensure that software releases meet defined quality, compliance, and performance criteria before deployment.Key Responsibilities:• Execute system-level V&V activities• Develop and execute V&V plans, protocols, and reports• Maintain requirements traceability and DHF documentation• Support and enhance automated regression testing• Ensure compliance with ISO 13485 and quality standards• Present test evidence and status during reviewsRequired Skills:5–6 years of Software Verification & Validation (V&V)Automation TestingManual TestingDevice-Level TestingTest Automation Tools & Automation Script DevelopmentRequirements TraceabilityTest Protocols, Reports & DocumentationDesign History File (DHF)ISO 13485 CompliancePreferred:Medical Device Industry ExperienceWet Lab Workflow KnowledgeSample Handling & Reagents UnderstandingHardware Testing Exposure