corrective-and-preventive-actions jobs in San Diego

Associate Systems Engineer supporting the development and enhancement of in-vitro diagnostic (IVD) instruments within a regulated medical device environment. The role involves system integration testing, verification and validation (V&V) activities, troubleshooting, failure investigations, and risk assessments across multiple R&D projects.…See more Responsibilities include executing statistical analyses, performing root cause analysis, contributing to design control documentation and regulatory submissions, and collaborating with cross-functional teams (software, hardware, assay development, quality, manufacturing). Requires a Bachelor's degree in Systems Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering, or related field with 0–3 years of relevant experience; Master's preferred.

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.