Ensure the entirety of the local quality management system, including Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, internal and Customer nonconformance management, Supplier Quality Audits, and Internal QMS Audits. Experience with development which includes authoring or supporting Test Method development (MSA, Gage RR, TMV, etc.), Product and process Validation Protocols/ Reports, risk assessments (pFMEAs, dFMEAs, etc.), Design of Experiments and Capability Analyses.