Amit Tyagi

About Amit Tyagi

A diligent QA / RA professional having 22+ Years of rich experience in Medical Device, Telecom and Optical Media industries. Major work domain includes Design Quality, Manufacturing QA, Corporate QA, Business QA (Service, Warehouse, Distribution & Commercials), Supplier Development and Management, New product development Quality Engineering, Process Validation and design validation. Having expertise on Quality and Regulatory I am having sound exposure on ISO 13485, ISO14971, 21CFR820, ISO9001, FDA Audit, Corporate audit etc. I am a certificated lead auditor for ISO13485 and also holding certificates as Six sigma green belt, ASQ CQE & Calibration system management. I have lead 200+ supplier and process audits and completed 5 six sigma projects to improve manufacturing and business processes. Leading RAQA team by developing quality plan, functional objectives, policies and procedures, including MR responsibilities such as planning and managing internal audits, MRM and external audits. Leading QMS implementation (ISO13485), business process integrations & improvements, complaint handling, PFA, recalls & supporting new product introductions by ensuring regulatory requirements.I am a subject matter expert for PCBA, SMT process, Box build (Sub-assembly), Injection molding, Metal injection molding and having proficiency with mechanical processes such as machining, heat treatment etc.Key Strengths: Strategic planning, development of objectives & KPISix Sigma Green Belt certified from TUV SUD Asia: Completed 5 six sigma projectsNew Product Development Quality EngineeringASQ CQE CertifiedISO13485:2016 Certificated Lead Auditor: Conducted 200+ 2nd party and L2 auditsISO 9001:2008 Internal auditorManagement Skills: Leading by example, Engaging and coaching teamRoot cause analysis & problem solving approach (DMAIC, 4D & 8D Methodology)Excellent interpersonal & communication skills

Experience

1. Quality Leader

   Philips

   Jan 2025 — Present · Bengaluru, IN

   Design Quality for Systems and Software, QMS, CAPA, Audit Management, Supplier Development and Management, ISO 13485, Risk Management, Process Validation

Education

• Symbiosis

  PGDBA, Business Administration, Management and Operations

  2009 — 2012

• Government Polytechnic, Shahjahanpur U.P. - India

  Diploma InElectronics Engg., Electronics, Telecommunication

  1999 — 2002

• Birla Institute of Technology and Science, Pilani

  Bachelor of Science (BS), Engineering and Technology

  2014 — 2017

Skills

• Testing
• Iso 9000
• Team Management
• Spc
• Iso
• Business Process Improvement
• Management
• Six Sigma
• Product Development
• Root Cause Analysis
• Process Improvement
• Failure Mode and Effects Analysis (Fmea)
• Kaizen
• Quality Assurance
• Management Skills
• Quality System
• Manufacturing
• Iso Standards
• Fmea