Frederick Preiss
Sr. Quality Scientist/Project Lead
Core Expertise
Mr. 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.
SPECIFIC SKILLS
ISO 13485 21CFR 820 (QS Requirements) 21 CFR 820.70 (Production & Process Controls) 21 CFR 820 .75 (Process Validation) CAPA 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 Sterilization Capital Equipment High and Low volume disposables Facility and Clean Room Layout Start up and Expansions Injection Molding Extrusion Casting & Machining Arthroscopic and Laparoscopic Devices Ablation Devices (RF and Cryo) Catheters Hip & Knee implants |
EXPERIENCE
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
EDUCATION
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
