Frederick Preiss

Sr. Quality Scientist/Project Lead

Core Expertise

Fred PreissMr. Preiss has functioned as a pioneer in many aspects of manufacturing, engineering, R & D, IT, materials and distribution.   Throughout his career, he has worked with senior management teams within the medical device, orthopedics and biotechnology industries.  Mr. Preiss has been well recognized for his ability to manage multiple projects simultaneously and has worked extensively within the confines of high pressure environments consisting of turnarounds, uncooperative workforces and underperforming companies.  He has robust experience in the areas of quality management, FDA compliance, engineering, re-engineering, process improvement and reduction of costs that yield increased profitability and improved overall productivity.  Mr. Preiss has excellent communication skills and prides himself on his strong ability to maintain relations with personnel ranging from the production floor to the executive boardroom.  



ISO 13485
21CFR 820 (QS Requirements)
21 CFR 820.70 (Production & Process Controls)
21 CFR 820 .75 (Process Validation)
483 Corrective Actions
Gap Analysis
Root Cause Analysis
Operating procedures & Training Records
FDA / GMP audits
Lean Six Sigma Black Belt
DOE Analysis
Failure Analysis
Process Capability
Pilot Operations
Class II and III devices
Capital Equipment
High and Low volume disposables
Facility and Clean Room Layout
Start up and Expansions
Injection Molding
Casting & Machining
Arthroscopic and Laparoscopic Devices
Ablation Devices (RF and Cryo)
Hip & Knee implants



Consultant – Sr. Quality Scientist/Project Lead – BIOSTAR CONSULTING, INC., Greenbrier, TN
Vice President, Operations – ATRICURE INC., West Chester, OH
Vice President, Operations- TELEFLEX MEDICAL, Jaffery, NH
Vice President, Operations – REGENERATION TECHNOLOGIES, INC., Gainesville, FL
Principal – Project Management, Bolton, CT
Executive Vice President, Operations – Wright Medical Technology, Memphis, TN
Vice President of Manufacturing – United States Surgical Corporation, Norwalk, CT



Bachelor of Science in Business Administration – University of New Haven, New Haven, CT
Associate of Science in Manufacturing Engineering, Norwalk State Technical College, Norwalk, CT
Lean Six Sigma Black Belt, Villanova University




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