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Katalyst CRO

Manufacturing Quality Engineer

Katalyst CRO, Bothell, Washington, United States, 98021

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Manufacturing Quality Engineer

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Katalyst CRO . Get AI-powered advice on this job and more exclusive features. Responsibilities

Manage Non-Conformance events including CAPA; partner with Supplier Quality on incoming, outgoing, WIP, and FG releases; resolve quality non-conformities with cross-functional stakeholders; improve Quality Management System. Handle Change Management related to manufacturing processes or controls, including NC/QN Management Process. Analyze defects to determine disposition of non-conformances. Contribute to operations performance monitoring, reporting, and improvement initiatives. Lead/support factory improvement programs. Assist Supplier Quality with investigations and communications as needed. Lead change management for process modifications in the factory. Oversee Material Review Board activities for nonconformance disposition management. Act as advisor to subordinates and cross-functional partners to meet schedules and solve technical issues. Develop and administer schedules and performance requirements. Work on diverse issues requiring evaluation of various factors, including current business trends. Follow operational policies and processes to select methods for solutions. Requirements

Bachelor's degree in engineering or equivalent experience. Minimum 5 years of related engineering experience, preferably in medical device or regulated industry. Experience in Quality Engineering and Continuous Improvement techniques. Critical to business and revenue. Responsible for CAPAs and manufacturing quality activities. Additional Details

Seniority level: Associate Employment type: Contract Job function: Quality Assurance Industry: Pharmaceutical Manufacturing This job posting is active. Location: Seattle, WA. Salary range: $105,000 - $160,000.

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