KH
Design Quality Engineer
Katalyst Healthcares & Life Sciences
🇨🇦 Canada | 🇺🇸 United States
On-site
2 months ago
- Risk Management
- Minitab
2 months ago
Not enough detail in this posting to match
- 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.
- 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.
- 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.
Design Quality Engineer · Katalyst Healthcares & Life Sciences