gage-r-r jobs in San Diego

Sr QA Engineer leading complex quality investigations, root cause analysis, CAPAs, and NCMRs at a regulated medical device company (Dexcom). Drives Quality Management System excellence through continuous improvement methodologies (Six Sigma, Lean, process capability analysis), owns validation and qualification strategies for equipment/processes/software, and guides design transfer and commercialization from development to high-volume manufacturing.…See more Requires advanced quality engineering knowledge, hands-on technical aptitude, proficiency with data analysis tools (JMP, Excel), and cross-functional leadership across R&D, Regulatory, Manufacturing, and Engineering teams.

Lead complex quality investigations and root cause analysis for a medical device company, driving CAPAs, NCMRs, and systemic corrective actions. Provide technical leadership in quality engineering methodologies including Six Sigma, Lean Manufacturing, process capability analysis, and risk-based problem solving.…See more Own validation and qualification strategies for equipment, processes, test methods, and software V&V across the product lifecycle. Partner with R&D, Regulatory Affairs, Manufacturing, and Engineering teams on design transfer, commercialization, and compliance initiatives while representing Quality during audits and regulatory inspections.

The Systems Engineer applies interdisciplinary expertise to define, develop, integrate, and test complex In Vitro Diagnostic systems for medical device applications. Responsibilities include documenting user and system requirements, decomposing system architecture into subsystems with defined interfaces, conducting hazard and risk analysis, managing configuration and change control, driving system integration and root-cause analysis, and supporting clinical validation.…See more The role requires 10+ years of industry experience with demonstrated mastery of the full product development lifecycle in medical device or regulated environments, including risk management, design reviews, and cross-functional collaboration with development, testing, and clinical teams.