Barry Mirrer

About Barry Mirrer

MIT-educated technology and quality professional with proven experience building teams, defining processes, fixing problems and making things work. • Builds trust with key stakeholders to generate results and achieve goals • Quick study with broad technical knowledge and experience using creative methods and tools to solve problems and design permanent solutions • Developed new departments and expanded existing departments at several companies; grew and mentored managers and individual contributors • Strong GCP (Good Clinical Practice) experience, including Late Phase Research and Real-World Evidence • Drives results while maintaining positive employee morale and engagement • Quality system experience includes GxP, ISO 9001, FDA 21 CFR Part 11, CMM • Defined, managed and rolled out multiple technical and process systems. • Champion of Quality in the organization; Fosters a Quality mindset in others • Cross-industry experience includes healthcare, software validation, wide-area and PC networking, multi-computing, fiber-optics manufacturing, semiconductor testing

Experience

1. Head of Quality Assurance

   PROMETRIKA, LLC

   Jul 2019 — Present · Cambridge, MA

Education

• Massachusetts Institute of Technology

  SB; SM

Skills

• Process Improvement
• U.s. Title 21 Cfr Part 11 Regulation
• Gcp
• Career Development
• U.s. Food and Drug Administration (Fda)
• Auditing
• Sdlc
• Software Documentation
• Innovative Problem Solver
• Software Maintenance
• Testing
• Business Process Improvement
• Iso 9001
• Quality Management
• Software Quality Assurance
• Document Management
• 21 Cfr Part 11
• Process Development
• Iso 13485
• Change Management
• Capa
• Clinical Trials
• Product Management
• Quality Auditing
• Quality Assurance
• Management
• Computer System Validation
• Fda
• Quality System
• Validation
• Software Development
• Iso
• Cross-Functional Team Leadership
• Sop
• Mentoring
• Quality Systems