fda-21-cfr-820 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.

Lead a team of Quality Engineers supporting high-volume manufacturing automation, product introductions, and process validation across multiple programs and sites at a regulated medical-device company. Establish strategic direction for quality engineering, Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities while partnering with Engineering, Operations, and R&D to identify and mitigate risks.…See more Drive continuous improvement through quality metrics, CAPA effectiveness, and nonconformance management, and represent Quality Engineering during audits and regulatory inspections. Manage departmental resources, budgets, and staffing while building and developing high-performing teams.

As Senior Staff Quality Engineer at Dexcom, you will drive quality compliance and inspection readiness across products, processes, and systems in a medical device environment. You'll lead complex investigations, implement corrective and preventive actions, mentor engineers, and ensure adherence to FDA 21 CFR 820 and ISO 13485 requirements.…See more The role requires hands-on expertise in QMS frameworks, design control, regulatory inspections, and the ability to influence stakeholders across engineering, operations, and global sites to maintain continuous audit readiness.

Staff QA Engineer at Dexcom leading manufacturing quality and regulatory compliance for continuous glucose monitoring devices. Responsibilities include directing Design Control and design transfer strategy, managing process validation and commercialization, leading cross-functional teams on complex technical and compliance matters, and providing expert guidance on Quality Management System governance (FMEA, CAPA, process controls).…See more Requires deep hands-on experience with FDA 21 CFR 820, ISO 13485, and related QMS requirements, plus ability to mentor teams and represent the organization during audits and regulatory inspections.