Quality Assurance Engineer III

Role: Quality Assurance Specialist supporting manufacturing compliance for Class III combination medical devices and blood components at Cerus, with a focus on software lifecycle, risk management, and regulatory adherence. Responsibilities: develop and maintain quality systems, oversee verification/validation activities, perform risk analyses, conduct audits, and support regulatory documentation including IEC 62304 cybersecurity and software testing requirements. Collaborate with cross-functional teams on product development, quality improvement, and CAPA investigations. Qualifications: Bachelor's in engineering or scientific discipline; 5+ years in QA/QMS supporting manufacturing of complex medical devices, ideally with hardware/software and blood component experience. Skills/Certifications: familiarity with IEC 62304, software risk management, defect management, and quality tools like FMEA, Six Sigma; quality certifications preferred. HighValue: experience with Class III medical devices, software lifecycle compliance, risk management, regulatory standards, and supplier quality management. WorkSetup: hybrid in Concord, CA with approximately 10% domestic/international travel.