Apply on Employer Site

Katalyst CRO · 2 months ago

Sr. Design Quality Engineer

Irvine, CA

Full-time

Onsite

Senior Level

Katalyst CRO is a company focused on quality engineering in the medical device industry. They are seeking a Senior Design Quality Engineer to ensure that engineering activities comply with regulatory standards and to collaborate with cross-functional teams on risk management and product validation.

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