Kamod Jha

About Kamod Jha

Senior Quality / Manufacturing Engineer with over twenty years of experience in process improvement, quality assurance, cost reduction, cycle time reduction, capital projects manage-ment and medical device / pharmaceutical regulated manufacturing industry. • Expertise in facility layouts, validation protocols, risk assessment and new product development cycles of medical devices, design control, Gage R&R, assembly, Poka-Yoke, 5WHYs, tool, testing, quality planning, implementation, and project management – $500K. • Excellent engineering tools skills, GD & T, and blueprint reading capabilities.• Process Improvement, Failure Investigation, Regulatory Compliance & Cost Reduction.• Root Cause Analysis (RCA), APQP / PPAP, Work Instructions and Time Study Experience.• New Product Management, Continuous Improvement, and data analysis of process defects.• Strong understanding of CI, lean, six sigma, 5S, 8D, VSM, & kaizen manufacturing processes.• Strong experience in application of Process Maps, PFMEA, MSA and other risk analysis tools.• Participate in FDA / BSI audit, Third party audit, Surveillance audit, Internal and External audit.• Strong knowledge of validations (IQ, OQ, PQ, TMV, VMP), DOE’s, QMS, GMPs, FDA, NCR, CAPA, SCAR, Deviation and 21 CFR 820, 21 CFR 210/211, ISO 9001 / ISO 13485, ISO 14971.

Experience

1. Quality Engineer Iii

   MilliporeSigma

   Apr 2024 — Present · Indianapolis, IN, US

   Reviewing and approving validation equipment qualification processes and parameters against quality and industry standards.• Reviews design plans, process procedures, test procedures, and raw data to understand the scope, requirements, and function of products.• Establish optimized validation qualification and validation planning and requirements. Developing test procedures that produce analyzable validation data. • Performing risk assessments and ensuring compliance with industry standards. Presenting validation test results and recommending improvements.

Education

• University of Colorado Boulder

  Master of Science, Mechanical Engineering

  2009 — 2010

• Magadh University

  Bachelor of Science, Mechanical Engineering

  1997 — 2002

Skills

• Pro Engineer
• Pro-E
• Nx Unigraphics
• Lean Manufacturing
• Six Sigma
• Minitab
• Root Cause Analysis
• Engineering
• 5s
• Spc
• C - Projects
• Visview & Vismockup
• Materials
• Manufacturing
• Powerpoint
• Autocad
• Process Improvement
• Project Management
• Solidworks
• Matrix
• Mechanical Engineering
• Fmea
• Kaizen
• Ms Office Suite
• Quality Management
• Infinityqs
• Ncca
• Contract Management
• Continuous Improvement
• Project Managment