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Katalyst Healthcares and Life Sciences

QA Engineer III

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


Responsibilities: Responsible with Change Management to manufacturing process or controls and: - NC/QN Management Process. Analysis of defect 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 non-conformance events and investigations in the Factory - Oversees Material Review board activities for non-conformance disposition management. Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Fully qualified managers who have advanced beyond entry level. Has working knowledge of company products and services. Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business Trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions. 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.Requirements: 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 manufacturing process or controls and NC/QN Management Process. Analysis of defect 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.