California Licensed Quality Engineer

Job Summary

A company is looking for a Senior Principal Quality Engineer specializing in Product Risk Assessments, Technical Investigations, and Improvements.

Key Responsibilities

• Lead investigations of complex product quality and compliance issues, analyzing results and making recommendations
• Manage the execution of complex experiments and tests to assess and improve products and manufacturing processes
• Optimize complex processes using engineering methods for continuous improvement and risk reduction

Required Qualifications

• Bachelor's degree in engineering or scientific field with at least 8 years of relevant experience, or a Master's degree with at least 7 years
• Proven experience in leading cross-functional root cause investigations and Product Risk Assessments (PRAs)
• Strong knowledge of CAPA, NCR, and complaint investigation processes
• Experience with Class III medical devices or implantable technologies
• Familiarity with FDA 21 CFR 820, ISO 13485, and ISO 14971