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Katalyst CRO · 1 month ago

Sr. Design Quality Engineer

Irvine, CA

Contract

Onsite

Senior Level

Katalyst CRO is a company focused on ensuring the quality of released products through stringent compliance with regulatory and internal standards. The Sr. Design Quality Engineer will collaborate with cross-functional teams to manage product risk documentation and support verification and validation processes while overseeing product testing and compliance.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

Qualification

Risk ManagementVerificationValidationStatistical AnalysisDesign ControlProblem Solving

Required