Quality Assurance Engineer

Quality Engineer – New Product Introduction (NPI) Irvine, CA 6-month contract We're seeking a Quality Engineer to support New Product Introduction (NPI) projects in a regulated manufacturing environment. In this role, you'll partner with Engineering, Operations, and Quality teams to help transfer new products into manufacturing while supporting quality, risk management, and process improvement initiatives. Responsibilities Partner with cross-functional teams throughout new product introduction and product launch activities. Lead or support process risk management activities, including PFMEA. Develop and improve inspection methods and quality control processes. Support design transfer and manufacturing readiness activities. Participate in process validation and continuous improvement initiatives. Support First Article Inspection (FAI) and PPAP activities as applicable. Help ensure compliance with applicable quality system and regulatory requirements, including ISO 14971. Required Qualifications Bachelor's degree in Engineering, Physical Sciences, Statistics, or a related technical field. 3+ years of Quality Engineering experience in a regulated manufacturing environment. Experience with: New Product Introduction (NPI) Process Risk Management (PFMEA) Inspection process development Strong collaboration and communication skills. Preferred Qualifications Master's degree in a related technical discipline. Experience with process validation. Knowledge of PPAP and Design Transfer. Familiarity with ISO 14971.