capa jobs in San Diego

The Senior Design Quality Engineer ensures digital health products comply with FDA regulations, quality standards, and user requirements through design controls and verification/validation activities. They manage digital health projects from concept to production using phase-gate approaches, lead or support CAPAs and NCRs, conduct internal/external audits, and apply risk management throughout the design lifecycle.…See more The role requires advanced knowledge of FDA design controls and IEC 62304 software standards, with hands-on experience taking products through regulatory compliance. The engineer will work independently, provide executive guidance on quality matters, and serve as a best-practice resource within their area of expertise.

Staff-level quality engineer responsible for new product introduction (NPI) of semiconductors and PCIe/server infrastructure for AI data centers. Will represent quality engineering across core development teams, drive reliability and supplier readiness, manage AQL sampling and non-conforming material disposition, and own product quality end-to-end from development through high-volume manufacturing.…See more Must lead corrective actions, supplier qualification, and risk mitigation while interfacing with customers and suppliers. Requires bachelor's degree in computer science or electrical engineering with 4+ years of hardware engineering experience (or equivalent advanced degree with less experience).

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.

Senior Software QA Engineer supporting Dexcom's Postmarket Investigations team to assess real-world product performance, investigate software and device issues, and drive continuous improvement. You will collaborate across R&D, Quality, Regulatory Affairs, and Clinical teams to conduct root-cause analyses, perform risk assessments (including hazard analysis, DFMEA, PFMEA), and translate postmarket insights into product enhancements.…See more The role requires deep technical understanding of software architecture, structured problem-solving, statistical analysis, and the ability to communicate findings to both technical and non-technical stakeholders while ensuring regulatory compliance and patient safety.

As a Systems Engineer, you will troubleshoot complex mechanical, electrical, and software issues in advanced 3D printing (ECAM) systems, identify root causes, and develop solutions to improve printer fleet performance. You'll analyze manufacturing and quality data to drive continuous improvement, apply structured problem-solving methodologies (8D, 5 Whys, Fishbone), and support corrective and preventive actions (CAPA).…See more You'll partner across mechanical, electrical, and software engineering teams to ensure system integration, develop technical documentation and SOPs, and execute functional test plans. The role requires hands-on troubleshooting of electromechanical systems, knowledge of quality tools and methodologies, and CAD expertise.

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections.…See more The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.

Lead software development for an FDA-cleared blood testing platform, overseeing instrument software, application software, cloud connectivity, cybersecurity, and software quality systems. Manage the full software development lifecycle including requirements, risk management, design controls, verification and validation, and regulatory compliance.…See more Work closely with Quality and Regulatory Affairs on FDA submissions, audits, documentation, and post-market support. Direct strategy, roadmap planning, architecture, and release management for a regulated in vitro diagnostic (IVD) medical device.