Design Quality Engineer
6 days ago
Design Quality Engineer at Katalyst CRO
Responsibilities- 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
Employment TypeContract
Job FunctionQuality Assurance
IndustriesPharmaceutical Manufacturing
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