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David Bortnick Location
Shrewsbury, MA, US
David Bortnick Work
Quality Manager @ (October 2025 - Present)
Quality Manager and Regulatory Manager @ (January 2023 - June 2025)
Quality System Manager @ (March 2021 - December 2022)
Manager Quality Assurance @ KARL STORZ Endovision (February 2018 - January 2021)
Sr. Quality Assurance Engineer and Engineer IV, Quality @ KARL STORZ Endovision (September 2013 - January 2018)
Principal Design Quality Engineer @ (November 2010 - August 2013)
David Bortnick Education
The University of Alabama in Huntsville
Bachelor of Science (Mechanical Engineering)
University of Colorado Denver
Architecture
Florida Institute of Technology
Business Administration and Management (General)
David Bortnick Skills
Audit Planning
Audit Preparation
Audit Process
Audit Reporting
Auditing Fundamentals
CAPA
Corrective and Preventive Action (CAPA)
Design Control
Design of Experiments
Document Management
FDA
FMEA
GMP
ISO 13485
Lean Manufacturing
Manufacturing
Medical Device Auditing
Medical Devices
Process Validation
Quality Assurance
Quality Auditing
Quality Management System Requirements
Quality System
Quality System Compliance
Quality System Regulation
Quality Systems Design
Quality Tools
Refurbishing
Refurbishment
Regulatory Affairs
Regulatory Laws and Requirements
Risk Management
Root Cause Analysis
Six Sigma
Statistics
Technical Medical Device Knowledge
Training
Training Skills
U.S. Food and Drug Administration (FDA)
V&V
Validation
Verification and Validation (V&V)
David Bortnick Summary
David Bortnick, based in Shrewsbury, MA, US, is currently a Quality Manager at Micron Solutions, Inc.. David Bortnick brings experience from previous roles at Canon USA, Healthcare Optics Research Laboratory, Canon U.S.A. and KARL STORZ Endovision. David Bortnick holds a Bachelor of Science in Mechanical Engineering @ The University of Alabama in Huntsville. With a robust skill set that includes Audit Planning, Audit Preparation, Audit Process, Audit Reporting, Auditing Fundamentals and more. David Bortnick has 1 emails and 1 mobile phone numbers on RocketReach.
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