Katalyst CRO
Overview
Quality Engineer role at Katalyst CRO. Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and driving continuous improvement initiatives within a regulated environment. Responsibilities
Support manufacturing process validation (IQ/OQ/PQ) to ensure compliance with regulatory standards. Lead and participate in CAPA investigations, root cause analysis, and implementation of corrective/preventive actions. Review and maintain documentation for validation protocols, reports, and quality records. Collaborate with cross-functional teams (Manufacturing, R&D, Quality) to resolve quality issues. Ensure compliance with FDA, ISO 13485, and GMP requirements for medical devices. Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency. Support internal and external audits/inspections as required. Qualifications
Experience in manufacturing processes, process validation, CAPA, and medical devices. Knowledge of FDA, ISO 13485, and GMP requirements for medical devices. Ability to collaborate with cross-functional teams and drive continuous improvement. Role Details
Seniority level: Associate Employment type: Contract Job function: Quality Assurance Industries: Pharmaceutical Manufacturing
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Quality Engineer role at Katalyst CRO. Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and driving continuous improvement initiatives within a regulated environment. Responsibilities
Support manufacturing process validation (IQ/OQ/PQ) to ensure compliance with regulatory standards. Lead and participate in CAPA investigations, root cause analysis, and implementation of corrective/preventive actions. Review and maintain documentation for validation protocols, reports, and quality records. Collaborate with cross-functional teams (Manufacturing, R&D, Quality) to resolve quality issues. Ensure compliance with FDA, ISO 13485, and GMP requirements for medical devices. Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency. Support internal and external audits/inspections as required. Qualifications
Experience in manufacturing processes, process validation, CAPA, and medical devices. Knowledge of FDA, ISO 13485, and GMP requirements for medical devices. Ability to collaborate with cross-functional teams and drive continuous improvement. Role Details
Seniority level: Associate Employment type: Contract Job function: Quality Assurance Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr