Ben Boytor

About Ben Boytor

With over 20 years of experience in Quality Leadership roles in the medical device and biologics industries, I pride myself on upholding the highest standards of integrity, drive, and accountability. My commitment to excellence is unwavering, and I thrive on ensuring that products not only meet but exceed quality and regulatory requirements.Throughout my career, I have led cross-functional teams to achieve groundbreaking innovations, driven by a relentless pursuit of quality and continuous improvement. I am passionate about fostering a culture of transparency, collaboration, and ethical decision-making, where every team member is empowered to contribute their best.I am dedicated to maintaining the highest level of accountability in all my endeavors, ensuring that projects are completed on time, within budget, and to the utmost satisfaction of stakeholders. My goal is to contribute to the development of safe, effective, and life-changing products that improve patient outcomes and enhance their quality of life.

Experience

1. Quality Core Team Lead

   BD

   Mar 2024 — Present

   As part of the Pharmacy Automation Core Team for new product development, responsible for integrating quality principles into the design process. Responsible for leading an extended team of quality associates including risk management, supplier quality and compliance engineering. Responsible for establishing core QMS elements required for delivering products that meet regulatory, quality and customer requirements.

Education

• Augustana College

  B.A., PreMedicine Biology

  1994 — 1998

• Florida International University

  M.S., Biomedical Engineering

  2001 — 2003

Skills

• Gmp
• Capa
• Quality System
• Medical Devices
• Quality Assurance
• Iso 13485
• Quality Management
• Continuous Improvement
• Change Control
• Fda
• 21 Cfr Part 11
• Fda Gmp
• Validation
• Biotechnology
• Iso 14971
• Supplier Quality
• Six Sigma
• Lean Manufacturing
• Design Control
• V&V
• Minitab
• Pma
• Process Improvement
• Manufacturing
• Sap
• Sop Development
• Start-Ups
• Leadership
• 21 Cfr
• Auditing
• Biologics
• Change Management
• Risk Management
• Ind
• Contract Manufacturing
• Training
• Statistical Tools
• Experienced Speaker
• Root Cause Analysis
• Product Innovation