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Design Quality Engineer

Katalyst HealthCares & Life Sciences

Job Description

Job Description

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 16 days ago
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