Katalyst Healthcares and Life Sciences
Quality Engineer
Katalyst Healthcares and Life Sciences, Minneapolis, Minnesota, United States, 55400
Job Description:
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.
Roles & 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.
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.