Quality Engineer

Role: Quality Engineer Location: Irvine, CA, Onsite Job Type: Contract About the Role We are looking for a Quality Engineer to support product and process quality activities, including validation, complaint investigations, and regulatory compliance. This role involves working closely with cross-functional teams to ensure products meet quality and regulatory standards. Key Responsibilities Support process, equipment, and method validation activities Write and execute test protocols and validation reports Assist in complaint investigations, CAPA, and non-conformance handling Perform root cause analysis and support corrective actions Work with cross-functional teams on production and process improvements Apply basic statistical analysis and quality metrics Ensure compliance with FDA / ISO / cGMP standards Required Skills & Experience 2–5 years of experience in Quality Engineering / Quality Assurance Hands-on exposure to validation (process/equipment/test methods) Experience with complaint handling, CAPA, or non-conformance Basic understanding of FDA, ISO (preferably ISO 13485), or cGMP Strong documentation and communication skills Experience in regulated manufacturing environment preferred Nice to Have Exposure to statistical tools / SPC Experience in medical devices or pharma industry