Sr. Design Quality Engineer

Sr. Design Quality Engineer at Katalyst CRO

• 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.