Adam Vepraskas

About Adam Vepraskas

ASQ Certified Quality Engineer• Knowledgeable in Quality Tools and Quality processes including validation and verification, FMEA (risk management), CAPA, DOE, root cause analysis tools, process improvement tools, metric tools, SPC run charts, sampling plans, statistical decision making techniques. • Expertise in all aspects of Quality Systems, FDA Medical Device Standards and Regulations (FDA CFR 21 820), and ISO standards (ISO13485 and 9001:2008). • Strong interpersonal skills with experience in conflict management, diplomatic communication, and cross-functional team leadership.• Excellent verbal and written communication skills. Experience with global virtual team management. • Excellent problem solving and analytical skills, time management skills, high degree of attention to detail, able to analyze data and determine appropriate actions. • Flexible, adaptable, and highly organized; can effectively manage multiple tasks and use resources to carry projects from concept through implementation in compliance with deadlines and budget• Skill designing and implementing many different procedures and projects • Proficient with TrackWise, Agile, Master Control, iTrak Complaint system, SAP, Oracle, Q-Pulse, Livelink, JMP, Excel, MiniTab, Word, PowerPoint, Visio, Outlook.

Experience

1. Senior Director Regulatory Affairs

   Exact Sciences

   Nov 2023 — Present

Education

• University of Wisconsin-Madison

  Bachelor of Science (B.S.), Medical Microbiology and Immunology

  2001 — 2005

Skills

• Cross-Functional Team Leadership
• Supplier Quality
• Iso 14971
• Root Cause Analysis
• Metrology
• Validation
• Software Validation
• Minitab
• Complaint Handling
• Equipment Validation
• Audit
• Specification Setting
• Dmaic
• Manufacturing Engineering
• Ce Marking
• Jmp
• Medical Devices
• Capa
• Fmea
• Design of Experiments
• Quality System
• V&V
• Iso 13485
• Design Control
• Fda
• Test Method Validation
• Process Validation
• 21 Cfr
• Spc