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Charles Setzer Location
Canton, NC, US
Charles Setzer Work
Senior RA and QA Analyst @ (April 2017 - Present)
Quality and Regulatory Affairs Manager @ (March 2007 - Present)
Regulatory Engineer @ (May 2006 - February 2008)
Owner @ Chuck Setzer Enterprises (May 2003 - May 2006)
Quality Manager @ (July 1997 - May 2002)
Quality Engineer @ (February 1992 - July 1997)
Charles Setzer Education
Mars Hill University
BS (Electronics Technology)
1985-1993
Fruitland Baptist Bible Institute
Diploma (Biblical Studies)
1983-1985
Charles Setzer Skills
Medical Devices
FDA
ISO 13485
Design Control
Quality System
Product Development
Regulatory Affairs
Quality Auditing
Manufacturing
Validation
V&V
GMP
Process Improvement
ISO 14971
CAPA
Injection Molding
Computer System Validation
Biotechnology
Product Launch
21 CFR
Supplier Quality
Sop
Biomedical Engineering
Medical Device Directive
Engineering
Continuous Improvement
ISO
Clinical Research
Quality Management
SPC
IEC 60601
FMEA
Quality Assurance
R&D
Regulatory Submissions
FDA GMP
Design for Manufacturing
Software Documentation
Lean Manufacturing
Design of Experiments
CQA
CE marking
Manufacturing Operations
Clinical Trials
Root Cause Analysis
Change Control
Hardware Diagnostics
Quality Control
Commercialization
CMDCAS
Regulatory
Product Management
Charles Setzer Summary
Charles Setzer, based in Canton, NC, US, is currently a Senior RA and QA Analyst at SunTech Medical. Charles Setzer brings experience from previous roles at SunTech Medical, Chuck Setzer Enterprises and Welch Allyn. Charles Setzer holds a 1985 - 1993 BS in Electronics Technology @ Mars Hill University. With a robust skill set that includes Medical Devices, FDA, ISO 13485, Design Control, Quality System and more. Charles Setzer has 1 emails and 1 mobile phone numbers on RocketReach.
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