sampling-plans 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.

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 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.

This Quality Assurance Engineer role supports medical device product development and sustaining engineering teams by developing and implementing quality test procedures, test equipment protocols, and sampling plans. The engineer will conduct product investigations, corrective/preventive actions, regulatory submissions support, and statistical analysis of production data—all in compliance with industry standards (ISO 14971), GMP, and regulatory requirements.…See more The role requires 4+ years in medical device/pharmaceutical quality engineering or equivalent advanced degree with 2+ years of relevant experience, with expertise in test method validation, equipment qualification (IQ/OQ/PQ), risk management documentation, and analytical equipment validation.