California Licensed Quality Engineer

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

May 20, 2025 - 04:30

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