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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 (Biochemistry)
1996-2001
Yoon Kim Skills
21 CFR Part 11
21 CFR Part 820
Agile & Waterfall Methodologies
Biotechnology
Business Process Improvement
CAPA
Certified ISO 9001 and ISO 13485 Lead Auditor
Complaint Management
Computer System Validation
Cross-functional Team Leadership
Design for Manufacturing
Document Management
Entrepreneurship
FDA
FDA GMP
Failure Mode and Effects Analysis (FMEA)
GMP
GxP
IEC 62304
ISO 13485
ISO 14971
ISO 17025
ISO 9001
Lean Process Improvement
Medical Devices
Mobile Devices
Operations Management
Outsourcing
Process Improvement
Product Development
Product Safety
Program Management
Quality Auditing
Quality Management
Regulatory Affairs
Regulatory Compliance
Software Development Life Cycle (SDLC)
Start-ups
Supplier Quality
System Development Life Cycle (SDLC)
Training & Development
V&V
Validation
Assessment
Maintenance
Microsoft Office
SQL
Customer Service
Start Ups
Cross Functional Team Leadership
System Development Life Cycle Sdlc
Sales
Management
Leadership
Training and Development
Failure Mode and Effects Analysis Fmea
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 Biochemistry @ California Polytechnic State University-San Luis Obispo. With a robust skill set that includes 21 CFR Part 11, 21 CFR Part 820, Agile & Waterfall Methodologies, Biotechnology, Business Process Improvement and more. Yoon Kim has 3 emails and 4 mobile phone numbers on RocketReach.
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