2006 -2008 Validation and Business analyst, Project Manager @
2005 -2006 Product and Process Transfer Scientist @ Celera Diagnostics
2003 -2005 Research Associate @
2001 -2003 R and D Scientist @
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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