Responsibilities:



Demonstrates ability of quality philosophies, principles, systems, methods, tools, and standards. Demonstrates understanding of the complaint process including types of complaints, investigation, root cause methodologies, execution, preparation of and reporting results and follow-up.



Develops and implements quality programs, including tracking, analyzing, reporting and problem solving.



Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling and measurement systems.



Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.



Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.



Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements



Requirements:



What is expected of you and others at this level Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform Client, CAPA and Complaint tasks and projects.



May contribute to the development of policies and procedures.



Develops technical solutions to a wide range of difficult problems.



Solutions are innovative and consistent with organization objectives Completes work independently receives general guidance and follows up.



Work reviewed for purpose of meeting objectives May act as a mentor to less experienced colleagues CAPA owner, Complaint Investigator and NC Coordinator a must.