Senior Quality Engineer Medical Device

Sr Quality Engineer – Medical device Location: Irvine, CA ( Fully Onsite) Duration: 12 Months Work Schedule: Fully Onsite – 5 Days/Week Position Summary The Sr Quality Engineer will support manufacturing quality and compliance for Medtronic Neurovascular products, including embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guidewires. This role will focus on process quality, validation, risk management, CAPA, nonconformance investigations, statistical analysis, and continuous improvement within a regulated medical device manufacturing environment. Key Responsibilities Develop, implement, and maintain quality standards and procedures for manufacturing processes and finished products. Partner with Manufacturing, Process Engineering, R&D, and Regulatory teams to resolve quality and process issues. Conduct inspections, testing, process evaluations, and statistical analysis to ensure product and process requirements are met. Troubleshoot manufacturing and equipment issues and drive effective technical resolutions. Lead root cause investigations using tools such as 5 Whys, 6M, Ishikawa, and Pareto analysis. Manage CAPA and NCMR investigations and implement corrective and preventive actions. Perform risk assessments using FMECA, DFMECA, and PFMECA methodologies. Develop and execute process validation and verification activities, including IQ, OQ, and PQ. Support Test Method Validation (TMV) and related documentation. Apply statistical process control, process capability, measurement system analysis, and tolerance interval techniques using Minitab. Support lean manufacturing and Six Sigma initiatives to improve process efficiency and product quality. Ensure manufacturing documentation, specifications, procedures, and sampling plans comply with applicable requirements. Provide technical guidance, training, and mentorship to junior quality engineers and technicians. Required Qualifications Bachelor’s degree in Engineering, Science, or a related technical field. 4+ years of relevant quality engineering experience; advanced degree with 2+ years may be considered. Medical device manufacturing experience strongly preferred. Minimum 2 years of experience with:FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP FMECA, DFMECA, PFMECA, and risk management Process Verification & Validation (IQ/OQ/PQ) Test Method Development and Validation (TMV) Root Cause Analysis and quality tools Six Sigma and Lean Manufacturing CAPA and NCMR investigations Minitab, statistical analysis, process capability, and MSA Manufacturing quality documentation, specifications, procedures, and sampling methods Preferred Experience Experience with vascular or neurovascular medical devices such as stents, catheters, embolic coils, guidewires, balloons, or aspiration devices. Strong understanding of manufacturing processes and process controls. Experience working in a highly regulated medical device environment. Ability to work independently, manage complex quality issues, and influence cross-functional teams.