Phaniendra Somraj
ISO 13483 Lead Auditor| Master Black Belt in LSS
About me
Phaniendra Somraj has held a variety of leadership roles in the Medical Device, Aerospace, Micro-Irrigation, Automotive industries as well as Consulting Services. He has global experience in his tenure leading global teams in countries like US, Italy, Romania, China and Australia. He has expertise in Lean Six Sigma principles completing successful Black Belt projects and has written a book to document a "Scientific & Simple Problem Solving Framework (SSPSF)" for problem solving in Enterprises.
He has in-depth knowledge in ISO 13485 and QSR regulations in addition to CAPA program, Internal Auditing, Continuous Improvement (Kaizen) projects, Validations and Verifications (IQ OQ PQ), 21 CFR Part 11, ISO 9001, ISO 14644, ISO 14971, Customer incident investigations, Root cause analysis, Value Stream mapping etc.
Education:
MS in Mechanical Engineering, University of Michigan, Ann Arbor | ME in Advanced Manufacturing Technology, University of South Australia, Adelaide | Bachelor of Technology in Mechanical Engineering, JNTU, India.
Certifications:
ISO 13485 2016 Lead Auditor | Master Black Belt in Lean Six Sigma | Certified Scrum Master | CMMI 2.0 Associate | Quality Process Analyst | Enterprise Design Thinking Practitioner | Tableau 10.0
His research "Design of a Bistable Compliant Locking Mechanism for New generation Mirror Actuator" from Centre for Advanced Manufacturing Research, University of South Australia, South Australia was published in 2005 ASME Florida conference
Authored a Book: Continuously Improve to Continuously Innovate: Journey to Innovate through Lean principles and Scientific & Simple Problem Solving Framework (SSPSF)
Speaker, Lean Six Sigma World Conference 2021, Florida, USA