Hiring: Senior Design Quality Engineer Company: Caris Life Sciences Location: Phoenix, AZ Job Posted Time: 2026-09-10 14:20:59 Target Skills & Keywords : GCP, Risk Management About the job Experience: •4+ years of hands-on experience, or relevant comparable background. Required Skills: •Lead and oversee creating the Design and Development Plan (DDP) for the new development projects, updating the DDP throughout the lifecycle of the product. •Create and maintain risk management file with support from cross-functional teams including risk management plan/report, hazard analysis, dFMEA, uFMEA. •Provide mentorship, guidance and training to the product development teams new to design controls and risk management processes. •Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications. •Manage deviation and issues for the verification and validation activities. •Support design reviews and design transfer activities including process validations, pFMEA and DMR. •Support design changes and post market activities, for example change controls and corrective and preventive actions (CAPA) to ensure product safety. •Perform risk assessments for the regulatory submissions. Qualifications: •Bachelor’s degree in engineering, scientific or related field. •Minimum 4+ years of hands-on experience, or relevant comparable background. •The ability to prepare and understand technical documentation such as technical reports, verification and validation protocols and reports. •Solid functional working knowledge of design controls, risk management and product development processes. •Solid functional working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems. •ISO 15189, CAP/CLIA and GCP/GCLP preferred. •Adaptable to fast-paced, dynamic work environment with shifting demands. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!