Design Quality Engineer

Design Quality Engineer at Katalyst CRO

• Lead and support design verification and validation activities, including test method development and execution.
• Perform sample size selection and statistical data analysis to support design decisions and risk assessments.
• Conduct process capability studies and support design transfer to manufacturing.
• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards.
• Collaborate with cross‑functional teams including R&D, Regulatory, and Manufacturing.
• Review and approve design documentation including Design History Files (DHF), risk management files and test protocols.
• Provide technical guidance and mentorship to junior QEs offshore.
• Support CAPA investigations related to design issues and contribute to continuous improvement initiatives.

• Certified Quality Engineer (CQE) or equivalent certification.
• Experience with software tools such as Minitab, JMP, or similar statistical analysis platforms.
• Familiarity with risk management standards (ISO 14971) and usability engineering (IEC 62366).
• Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820).

Associate

Contract

Quality Assurance

Pharmaceutical Manufacturing