Shawn Davis

Background

About Shawn Davis

Focus on Quality-centric jobs leading engineering or manufacturing programs to ensure regulatory guidance is met while utilizing my experiences with FDA enforced practices and methodologies. Potential career moves would have me taking more active leadership roles, preferably focused on improving a company’s implementation around pre- and post-market activities required by the FDA or other governing bodies involving all functional areas of product development and manufacture. I am a highly energetic, personable person who enjoys managing teams and interacting with cross-functional groups across all levels of management. My sound decision-making is evident in my accomplishments where I have been able to deliver and be a top performer within large and small organizations. Specialties: ISO 14971 Risk Management Principles Experience with FDA Quality Systems, EU Medical Device Directive (93/42/EEC), and ISO 13485 Experience and understanding of IEC 62304 Familiarity with automated testing tools and scripting languages Experience with non-product software validation Six Sigma – Greenbelt certified (DMAIC and DFSS) Lean Six Sigma – Lean leader and facilitator Verification and Validation Principles Project Leadership FDA Software Validation