Manufacturing Quality Engineering Co-op

      Participate in the investigation of failures and formulation/implementation of action plans for non-conformances, internal corrective actions, and audit findings.

·             Work in cross-functional teams to identify and address non-conformances throughout assembly to final shipment of product.  

·             Work with engineering teams to ensure quality procedures are followed in all manufacturing and distributing areas.

·             Use Lean and Six Sigma tools to analyze non-conformance data and identify opportunities for improvement across Material Review Boards (MRB) and other processes. 

·             Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.

·             Assist in the development and maintenance of quality documentation, including investigation reports, correction efforts, CAPAs, and process FMEAs.

·             Assist in reviewing process validations and equipment qualifications, including plans, protocols, and reports. 

·             Utilize software tools to capture non-conformance data in order to analyze and identify trends for corrective actions or escalations.