process-capability jobs in San Diego

Staff QA Engineer role at Dexcom leading quality engineering for high-volume manufacturing automation, design control, and process validation. Responsibilities include interpreting FDA 21 CFR 820 and ISO 13485 requirements, architecting validation strategies, driving design transfer for commercial deployment, leading complex investigations and CAPA initiatives, and mentoring cross-functional teams.…See more Requires deep expertise in root cause analysis, Six Sigma, process validation, statistical analysis, and data-driven decision-making across global sites.

Staff QA Engineer at Dexcom leading manufacturing quality engineering and design control for high-volume medical device automation. The role requires deep expertise in FDA 21 CFR 820 and ISO 13485 compliance, design transfer strategy, process validation, and CAPA/MRB leadership across global manufacturing sites.…See more You will mentor cross-functional teams, drive systemic quality improvements, and represent the organization during regulatory inspections, with strong emphasis on data-driven decision-making and risk-based design methodologies.

Development Engineer II will read and interpret engineering print specifications, participate in the quoting process, and document process parameters for precision manufacturing projects per quality systems requirements. The role requires writing basic programs to measure products using computer-controlled metrology equipment, with experience in Test Method Validations (TMV), GRR, process capability, and DOE.…See more The engineer will lead sections of the production-readiness process, mentor junior technicians, and communicate technical content internally and externally. Required qualifications include a BS in engineering/science, proficiency with GD&T, 2D/3D CAD software, Microsoft Office suite, and hands-on experience with computer-controlled measurement systems.