Essential Functions, Duties and Responsibilities:  Report to Executive VP of Quality on a regular basis regarding status of ongoing projects Ensure Smartsheet (project management cloud based software) accurately reflects timelines and responsibility assignment Support quality compliance needs from design control through commercial distribution. Coordinate and/or directly review and approve design history files, device master records, and device history record documentation. Working with engineering to develop, review and approve verification and validation protocols, work instructions, forms and reports. Facilitate initiation and closure of CAPAs, complaints, and NCRs Compile and institute quality metrics to present at