iq-oq-pq-pv 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.