Katalyst CRO
Responsibilities
Develop and execute validation protocols (IQ/OQ/PQ), capability studies, and risk analyses (pFMEA).
Support First Article Inspections, customer requirements, and regulatory compliance.
Manage nonconformance investigations, CAPA, and supplier corrective actions.
Develop and maintain quality documentation, test methods, and process standards.
Provide support to manufacturing teams during process changes and quality issues.
Assist with audits, customer complaints, and training of staff on quality methods.
Requirements
Bachelor's degree in engineering or related experience in Quality Assurance.
Strong knowledge of ISO 13485, FDA QSR, and validation requirements (IQ/OQ/PQ).
Experience with GD&T, metrology, statistical analysis, and quality tools.
Excellent communication, problem-solving, and cross‑functional collaboration skills.
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Develop and execute validation protocols (IQ/OQ/PQ), capability studies, and risk analyses (pFMEA).
Support First Article Inspections, customer requirements, and regulatory compliance.
Manage nonconformance investigations, CAPA, and supplier corrective actions.
Develop and maintain quality documentation, test methods, and process standards.
Provide support to manufacturing teams during process changes and quality issues.
Assist with audits, customer complaints, and training of staff on quality methods.
Requirements
Bachelor's degree in engineering or related experience in Quality Assurance.
Strong knowledge of ISO 13485, FDA QSR, and validation requirements (IQ/OQ/PQ).
Experience with GD&T, metrology, statistical analysis, and quality tools.
Excellent communication, problem-solving, and cross‑functional collaboration skills.
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