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.