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Katalyst Healthcares and Life Sciences

QA Engineer III

Katalyst Healthcares and Life Sciences, New Kensington, Pennsylvania, us, 15069

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Responsibilities: Non-Conformances events including CAPA management when required. Local Factory level QMS Process owner for Process validation. Partner with SQ on incoming, outgoing, WIP Receiving Inspection /WIP inspection /FG Release Transfer Integrations Resolve quality non-conformities with Philips internal suppliers. Analytical Testing Support SQE/SQA/Purchasing Product Ship Holds & Communications. Responsible with Change Management to the manufacturing process or controls and NC/QN Management Process. Analysis of defects for determining disposition of non-conformances. Contribute to Operations performance monitoring, reporting, improvement, and development. Responsible with improvement programs in factory. Assists Supplier Quality with investigations and may assist with Supplier Communications, as required. Leads change management for process changes in the factory. Responsible for nonconformance events and investigations in the Factory. Oversees Material. Review board activities non-conformance disposition management. Requirements: Bachelor's degree in engineering science, or equivalent experience Minimum of 5 years of related engineering experience (medical device or regulated industry preferred). Wide-ranging experience within an engineering function. Well-versed in Quality Engineering and Continuous Improvement techniques. Direct working relationships with suppliers - Participated in several NPIs from start to finish. Direct shop-floor production engineering sustaining experience.