Ujjwal Jain

About Ujjwal Jain

Drive product quality and objectives by collaborating effectively with Design, Development, Regulatory Affairs, Quality, and other cross-functional partners to define, allocate, and implement the quality objectives for Software/Firmware/Instrument products2. 15+ years’ experience with Class I, II and Medical Device design/quality assurance, design controls and risk management, including SaMD, SiMD3. Proficient in CAPA, Supplier Management, Internal Audit, Document Control4. Design History File remediation and Quality System integration activities5. Risk Management activities including Post Market Surveillance 6. Implement ISO 14971 and IEC 62304 procedures for ISO 13485 certification7. Product Cybersecurity Implementation and Integration with QMS (both Pre & Post Market)8. Proficient in US and International regulations including ISO 13485, ISO 9001, FDA QSR, IVDR/IVDD, MDD, ISO 14971, IEC 62304, 21 CFR 820, 21 CFR Part 11, TIR 45 and Tech File documentation9. Provided management oversight on CSV to CSA transition, including non-product software validations and deployments10. Conduct and support internal/external audits including FDA and Notified Bodies11. Extensive experience with development for medical as well as enterprise applications12. Agile Implementation (TIR 45) with IEC 62304 for Iterative Development13. Technical Management as well as managing team members (People Management) 14. Liaison member to Software and Cybersecurity AAMI committees

Experience

1. Director of Digital Quality

   Illumina

   Nov 2024 — Present · US

   Manage Digital and Validation Quality domain. Support Product Security, Non Product (Manufacturing systems, Production systems and Quality systems) and Technology Enablement (E.g, AI/ML).Lead EU AI Act adoption into the Corporate QMS.Partner with Product, Manufacturing, IT, Cybersecurity leaders.Expertise: Cybersecurity, Enterprise, AI and Software.

Education

• University of Florida

  MS, Computer Engineering

  2005 — 2008

• BBDNITM, Lucknow

  Bachelor’s Degree, Computer Engineering

  2000 — 2004

• Uttar Pradesh Technical University

  Bachelor's degree, Computer Engineering

  2000 — 2004

Skills

• Fda
• Internal Audit
• Quality Control
• Quality System
• Quality Systems
• V&V
• Document Management
• Medical Devices
• Capa
• Software Documentation
• Sdlc
• Root Cause Analysis
• 21 Cfr Part 11
• Design Control
• Software Development
• Data Analysis
• Six Sigma
• Quality Auditing
• Minitab
• Quality Management
• Software Project Management
• Reliability Engineering
• Itil
• Validation
• Databases
• Process Improvement
• Quality Improvement
• Dmaic
• Software Quality
• Testing
• Product Development
• R&D
• Risk Management
• Sql
• Iso 13485
• Fmea
• Qsr
• Cross-Functional Team Leadership
• Supplier Quality
• Iso 14971