2021 -2022 Quality Systems Manager and Management Representative @
2014 -2021 Quality Assurance Manager @ Refocus Group, Inc.
2013 -2014 Senior Quality Systems Specialist @
2010 -2013 Quality Systems Engineer @
2007 -2010 Quality Engineer @
2006 -2007 Application Analyst @
2004 -2005 Project Engineer @
2000 -2004 Control System Engineer @
1996 -2000 Emergency Room @
1992 -1996 Petty Officer Third Class Hospital Corpsman @
Thomas Hoffmann Education
The University of Texas at Arlington
Bachelor of Science - BS (Electrical and Electronics Engineering)
Thomas Hoffmann Skills
Post Market Surveillance
Risk Management
Corrective and Preventive Action (CAPA)
Critical Thinking
Design Assurance
Regulatory Compliance
Startups
Management Review
Verification and Validation (V&V)
Design Review
Leadership
Technical Files
Regulatory Strategy
Good Manufacturing Practice (GMP)
Regulatory Submissions
Statistical Data Analysis
Premarket Approval (PMA)
510(k)
Good Clinical Practice (GCP)
Quality System
Quality Assurance
SaMD
Human Factors Engineering
Design Control
ISO 13485
Medical Devices
FDA
IEC 60601
FMEA
Medical Device Regulation (MDR)
Product Development
Electrical Engineering
IEC 62304
ISO 13485 Lead Auditor
ISO 14971
Root Cause Analysis
CAPA
CQE
21 CFR Part 11
IDE
Design of Experiments
Six Sigma
Quality Control
Quality Auditing
Quality Management
Cross-functional Team Leadership
Design for Manufacturing
Project Management
Class III Medical Devices
Quality Engineering
Validation
Supplier Quality
Manufacturing
Kaizen
ISO
GMP
DMAIC
Process Simulation
Minitab
Process Engineering
Electronics
21 CFR
Lean Manufacturing
Change Control
SPC
Biomedical Engineering
FDA GMP
Process Improvement
Product Design
Part 820
Medical Device Directive
Process Validation
Design Validation
software
PMA
Iso 9000
Class Iii Medical
Sales
Sales Manager
Public Speaking
Microsoft Excel
Microsoft Office
Management
Thomas Hoffmann Summary
Thomas Hoffmann, based in Boston, MA, US, is currently a Senior Manager Design Quality Assurance at Insulet Corporation. Thomas Hoffmann brings experience from previous roles at Biofourmis, AnX Robotica Corp, Refocus Group, Inc. and Medtronic. Thomas Hoffmann holds a Bachelor of Science - BS in Electrical and Electronics Engineering @ The University of Texas at Arlington. With a robust skill set that includes Post Market Surveillance, Risk Management, Corrective and Preventive Action (CAPA), Critical Thinking, Design Assurance and more. Thomas Hoffmann has 3 emails and 2 mobile phone numbers on RocketReach.
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