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Yoon Kim Location
California, United States
Yoon Kim Work
Senior Director of Operations @ (July 2026 - Present)
Senior Director of Global Quality @ (May 2023 - July 2026)
Senior Director of Design Quality Engineering @ (May 2021 - May 2023)
Director of Global Quality and Regulatory Compliance @ (July 2019 - May 2021)
Director Of Quality, Technical Support @ (July 2018 - July 2019)
Global Senior Quality Manager @ (January 2018 - July 2018)
Director of Quality Management and Program Management - Cyber Security Software @ (April 2016 - December 2017)
Head of Quality and Regulatory Affairs, MFG Operations @ (June 2015 - April 2016)
Global Quality Manager - Operations, QA @ (May 2014 - June 2015)
Global Quality Manager - QA, QMS, Regulatory Compliance @ (May 2012 - May 2014)
Product Quality Engineer @ (September 2009 - May 2012)
QA Engineer @ (January 2008 - September 2009)
Validation and Business analyst, Project Manager @ (April 2006 - January 2008)
Product and Process Transfer Scientist @ Celera Diagnostics (June 2005 - April 2006)
Research Associate @ (February 2003 - June 2005)
R and D Scientist @ (June 2001 - January 2003)
Yoon Kim Education
California Polytechnic State University-San Luis Obispo
BS (BS, Biochemistry)
1996-2001
Yoon Kim Skills
Validation
Quality Management
Biotechnology
Medical Devices
ISO 13485
Process Improvement
FDA
CAPA
GMP
V&V
Design for Manufacturing
21 CFR Part 11
Certified ISO 9001 and ISO 13485 Lead Auditor
ISO 17025
ISO 9001
21 CFR Part 820
Product Safety
System Development Life Cycle (SDLC)
Computer System Validation
GxP
Mobile Devices
FDA GMP
Cross-functional Team Leadership
Supplier Quality
Quality Auditing
Complaint Management
Regulatory Affairs
Regulatory Compliance
Entrepreneurship
Start-ups
Product Development
Outsourcing
Assessment
Maintenance
Microsoft Office
SQL
Customer Service
Start Ups
Cross Functional Team Leadership
System Development Life Cycle Sdlc
Sales
Management
Leadership
Lean Process Improvement
ISO 14971
Training and Development
IEC 62304
Operations Management
Program Management
Document Management
Failure Mode and Effects Analysis Fmea
Business Process Improvement
Agile and Waterfall Methodologies
Software Development Life Cycle Sdlc
System Development Life Cycle
Software Development Life Cycle
Failure Mode and Effects Analysis
Yoon Kim Summary
Yoon Kim, based in California, United States, is currently a Senior Director of Operations at Thermo Fisher Scientific. Yoon Kim brings experience from previous roles at Thermo Fisher Scientific. Yoon Kim holds a 1996 - 2001 BS in BS, Biochemistry @ California Polytechnic State University-San Luis Obispo. With a robust skill set that includes Validation, Quality Management, Biotechnology, Medical Devices, ISO 13485 and more. Yoon Kim has 3 emails and 4 mobile phone numbers on RocketReach.
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