Sr. Design Quality Engineer

Katalyst HealthCares & Life Sciences

Full-time Irvine, California Engineers

Posted:

March 03, 2026

Location:

Irvine, California, United States

Job Description

Ensure quality engineering activities for released products comply with regulatory and internal standards. 
Collaborate with cross-functional teams to develop product risk management documentation, including Risk Management Plans, Risk Assessments, DFMEA, and Risk Management Reports. 
Support the development and execution of Verification and Validation (V&V) plans, protocols, and reports, Test Method Validation, as well as process validation activities (PFMEA, IQ, OQ, PQ) using statistical tools (, Minitab) for data analysis and decision-making. 
Oversee product testing and analysis to ensure compliance with applicable standards and requirements. 
Apply Design Control principles to support sustaining engineering efforts, including design updates and product enhancements. 
Resolve quality issues, manage design changes, and assess risks in partnership with engineering, manufacturing, and quality teams. 
Apply risk management...
                

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Job Overview

Job Type: Full-time

Location: Irvine, United States

Posted: March 03, 2026

Deadline: April 12, 2026