Karthik Kunnam

About Karthik Kunnam

I believe a good pair of hands, strong back, intellectuality and commitment to ethical work are the basic qualifications an Engineer from any industry should got.I am a Project Manager and Sr. Quality Engineer with over 7 years of professional experience inside Medical, Electronic and Automotive industries. I hold a Master of Mechanical Eng.(MME) degree. And, I am Project Management Professional certified (PMP|PMI), Certified Quality Engineer (CQE|ASQ) and Certified Quality Process Analyst (CQPA|ASQ). I have thorough understanding and application of Project Management, ISO 13485, ISO 14971, ISO 9001, EU MDR 2017/745, 21 CFR part 11, FDA, IATF 16949 QMS and Regulatory policies. I carry hands-on with NPD, Risk Management Documents, PMS, CAPA Investigations, Pilot Runs, Production Line Monitoring, Acceptance Sampling, Gage R&R, Equipment Verification and Validation. I expertise in Statistical Analysis (Control Charts), Capability Studies (Cp, Cpk, Pp, Ppk), Kanban, Lean, Six Sigma, Predictive, Hybrid and Agile Project Management methodologies. I lead and coordinated Spec Evaluations, Material Disposition, Team Scheduling and Organizing, Design V&V, CAPA Root-Cause Analysis, Clinical Data Reporting, NCR Correction and Internal Audits. From the projects and experience I had theoretically and practically, I am tested and qualified with skills to leverage my attention to detail, critical thinking, strong communication, ability to be cross-trained, dependability and interest for technology.

Experience

1. Sr Quality Engineer

   Fusion Life Sciences Technologies LLC

   Feb 2021 — Present · Alpharetta, GA, US

Education

• Vellore Institute of Technology

  Bachelors Degree, Mechanical Engineering

• University of South Florida

  Master's degree, Mechanical Engineering