Quality Engineer II

Role: Quality Engineer II supporting Class III medical device development and manufacturing, focusing on product quality resolution, process improvements, and validation activities. Responsibilities: investigate product nonconformities, review process changes, lead CAPA and complaint evaluations, develop trend analyses, write and review validation protocols, and ensure compliance with regulations such as GMP and ISO 13485. Also, manage equipment, conduct risk analyses, and support continuous quality improvements. Requirements: Bachelor's in Engineering or Science; 2-5 years in medical device quality assurance; strong knowledge of manufacturing, GMP, ISO 13485, and statistical tools; experience with validation protocols, risk management, and working in clean room environments. Preferred: hands-on experience with in-process assembly and manufacturing verification. HighValue: Class III medical devices, quality systems, validation protocols, risk analysis, GMP and ISO 13485 compliance, process improvements. WorkSetup: on-site in San Clemente, CA; no travel specified.