Sr. Design Quality Engineering

Title : Sr. Design Quality Engineering

Location : Irvine, CA

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 (e.g., 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 techniques to proactively identify and mitigate product risks.

Use structured problem-solving methodologies to address product and process challenges.

Communicate findings effectively through presentations, technical reports, and cross-functional collaboration.