Maggie Cronin-Kennedy

Greater Denver Area United States

Sr. RA/QA Specialist

Medical / Health Care / Pharmaceuticals

Some of my background highlights. I have utilized my experience and training across several industries---Telecommunications, Aerospace, Brewery Business, Pharmaceutical and Medical Device. Expert knowledge of 21 CFR 820 FDA, CMMI, Six Sigma, RCA (multiple ISO STDs--ISO 9001/13485/14971/17025 & 14001), IEC 62304, SOR/98-282, TL9000, AS9100, DO 178 B and DO 200 A and Baldrige). Highlights include:  I have built several Quality Management Systems from start to finish as well as improving and updating existing systems to become compliant with FDA and ISO 13485.  Developed Lean Six Sigma and PDCA process maps for use in executing healthcare projects for process improvement and cost ...