Katalyst CRO
Design Quality Engineer
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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. Qualifications
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). Seniority Level
Associate Employment Type
Contract Job Function
Quality Assurance Industries
Pharmaceutical Manufacturing
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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. Qualifications
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). Seniority Level
Associate Employment Type
Contract Job Function
Quality Assurance Industries
Pharmaceutical Manufacturing
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