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Design Quality Engineer

Katalyst HealthCares & Life Sciences

Job Summary: The Design Quality Engineer (DQE) ensures quality engineering activities for released products comply with regulatory and internal standards. The role supports sustaining engineering efforts through Design Control principles, design updates, continuous improvement activities, and collaborates with cross-functional teams to resolve quality issues and enhance product performance. Roles & Responsibilities: Ensure quality engineering activities for released products comply with applicable regulatory requirements and internal standards. Apply Design Control principles to support sustaining engineering efforts, including design updates and product enhancements. Define quality criteria for design changes and component updates. Collaborate with cross-functional teams to resolve quality issues, assess design changes, and improve processes. Apply risk management techniques to identify, evaluate, and mitigate product and process risks. Conduct Test Method Validation (TMV) to ensure measurement systems are suitable for intended use. Perform root cause analysis to resolve product quality issues. Apply structured problem-solving methods to address product and process challenges. Education & Experience: Bachelor's degree in Engineering or a related technical discipline. Experience in Quality Engineering or a related domain. Knowledge of Design Control principles and quality engineering practices. Experience in root cause analysis, test validation, and statistical data analysis. Familiarity with risk management and problem-solving methodologies. Proficiency in statistical tools (e.g., Minitab or similar). Strong written and verbal communication skills.

Vacancy posted 7 hours ago
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