This position requires a strong background in Pharmaceutical or Medical Device Quality Management. H/She will insure the reporting of timely and detailed non-conformance investigations. Requires demonstrated root cause analysis, investigation and technical report-writing skills. Responsible for staff development to focus on process improvement and the use of basic and advanced quality engineering tools such as SPC and DOE. Candidate will provide leadership to Operations on cGMP and other compliance requirements. Previous experience as a direct interface during FDA inspections is a plus.