Jeff Kim

Senior Principal Consultant & Associate Director of Quality Systems

Jeff Kim has over 20 years experience in the Medical Device industry ranging from Fortune 100 companies to early startups. His career has spanned product development, project management, and quality at the senior management level. He has extensive technical experience with all stages of the product development cycle as well as an in-depth knowledge of quality systems. He has led multiple FDA and ISO inspections. Since joining Suttons Creek, Jeff has leveraged his expertise with multiple clients in the combination product space.

Academic & Professional Qualifications:
  • B.S. Biomedical Engineering, Duke University
  • Master of Engineering Management, Duke University
Training, Quality Systems, & Specialties:
  • FDA Quality System Regulation / GMP / Combination Products
  • EU Medical Device Directive (MDD)
  • ISO 13485 Medical Device Quality Management Systems
  • ISO 14971 Risk Management
  • ISO 11040 Prefilled Syringes
  • ISO 11608 Needle injection systems / Autoinjectors