Staff Quality Engineer

Staff Quality Engineer – Contract Location: San Jose, CA Client: Medical Device Company Employment Type: Contract on W2. US Citizens or Green Card holders only. No H1B. Hours: 9am-5pm, 40 hours per week, first shift, hybrid schedule. Must reside within Northern California. Duration: 12+ months. Responsibilities Perform process, equipment, and software validation activities (IQ, OQ, PQ). Gather historical data for product manufacture, analyze with statistical principles, write validation protocols and reports. Review GDP data and reports, approve validation protocols, reports, and deviations. Act as Quality Assurance reviewer/approver or author for validation documents. Provide quality engineering direction using statistical principles. Lead or participate in cross‑functional teams including Reagent Manufacturing Engineers, Chemists, R&D, and QA Validation Engineers. Maintain concurrent projects. Apply root‑cause analysis, FMEA, risk management, DOE, measurement systems analysis, sampling and control plans, post‑market surveillance trend review, and process capability assessments. Follow company procedures and demonstrate working knowledge of applicable regulatory requirements. Other duties as assigned. Qualifications Bachelor’s degree. Experience in a quality related function in a medical device or other FDA regulated environment. Previous work with IVD reagent products under GMP conditions. Process validation (IQ, OQ, PQ) and test method validation experience. Software validation experience. Knowledge of general reagent manufacturing processes, antibody purification and conjugation, and flow cytometry. Certified Quality Engineer or Six Sigma Certification. Knowledge of applicable regulatory requirements: ISO13485, ISO14971, ISO9001, 21 CFR 820. Training in statistics; experience with Minitab or other statistical software, MS Excel, and MS Word. #J-18808-Ljbffr