Andrew Staut
Senior Manager, Post Market Quality @Boston Scientific
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WORK HISTORY
Senior Manager, Post Market Quality @Boston Scientific
Minneapolis, MN, US
Lead direct team of seven supporting Post Market complaint product investigation within the Interventional Cardiology Division Complaint Investigation Site (CIS). Products supported include single use device (SUD) diagnostic, dilatation, imaging, and guide catheters, guidewires, stents, and electronic medical Capital Equipment systems. Team conducts physical product analysis and testing as well as data analysis and trending of complaint data to support product performance improvement, regulatory complaint reporting, and new product design. Scope of work including transfer of Capital Equipment processes from California to Minnesota. Maintain CIS lab and supporting equipment. Improve Boston Scientific Post Market processes, policies, and procedures. Maintain compliance to FDA 21 CFR Part 820, FDA 21 CFR Part 803, ISO 13485, and Medical Device Regulations (MDR), among other worldwide medical device laws and regulations.
EDUCATION
Webster University
MBA, Business Administration
UMN Carlson School of Management
BSB, Marketing major, finance minor
SKILLS
ABOUT ANDREW STAUT
Medical Device Quality, Quality Systems, Manufacturing, and Project manager with diverse experience in operations, project management, integration, coordination and logistics planning. Direct experience leading both cross-functional and direct reporting teams within civilian and government operations.Specialties: Project Management Professional Certification, Level 1 Certification in Program Management and Acquisition Logistics (Dept of Defense)
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