2) Collaborate with the System Team to complete the standardized forms for the Customer Quality Management System standards.
Responsibility 2: Lead the implementation of a Quality Management System module within the EPROS system for a specific strategic customer's factory;
1) Lead the development of the Customer Quality Management System module within the EPROS system – e.g., maintaining the eight major processes and standardized forms for Customer S, documenting successful case studies, and replicating these practices across other factories;
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Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution.
Review and verify completeness and accuracy of Device History Records (DHRs) to ensure all manufacturing, inspection, and testing activities are properly documented and meet product specifications and regulatory requirements
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Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
Ensure and monitor the applicable documents for Quality inspection are available in the point of use, this includes, but is not limited to the visual aids with physical samples.
Continuously assess and improve incoming quality inspection processes to enhance efficiency, accuracy, and reliability. Identify opportunities for automation and optimization to streamline workflows
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Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution
Leads and/or participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
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