Manish Kumar

About Manish Kumar

I’m a Medical Device Quality Engineer with 10+ years of experience ensuring that life-saving medical technologies meet the highest standards of safety, quality, and regulatory compliance.My expertise spans Component Qualification (PPAP), Labeling & Packaging Compliance, Technical Documentation, CAPA & Non-Conformance Management, and Regulatory Readiness under EU MDR 2017/745, ISO 13485, ISO 14971, and 21 CFR 820.Over the years, I’ve: Led qualification for 500+ components used in robotic surgical devices and accessories. Executed 800+ label and IFU updates for global MDR transition projects. Developed and implemented biocompatibility, sterilization, and packaging validation protocols per ISO 10993, ISO and ISO 11607. Guided cross-functional teams of 8–10 associates to deliver projects ahead of schedule with full regulatory compliance. Drove process improvements that reduced qualification cycle time and labeling costs by over 40%.I’m deeply passionate about bridging quality engineering and regulatory expectations — transforming compliance activities into business enablers that ensure product reliability and patient safety.My collaborative approach has helped teams across R&D, Manufacturing, Supplier Quality, and Regulatory Affairs align toward shared goals — delivering safe, compliant, and effective medical devices for global markets.Certified as an IRCA Lead Auditor for ISO 13485 and trained in ISO 14971:2019 Risk Management and Process Validation (IQ/OQ/PQ), I’m always eager to stay current with evolving medical device standards and drive continuous improvement across systems and teams.If you’re passionate about quality systems, regulatory excellence, or process optimization in medical devices, let’s connect — I enjoy sharing insights, learning from peers, and collaborating on projects that make a difference in patient care.

Experience

1. Quality Assurance Specialist

   Tata Consultancy Services

   Jan 2026 — Present · Cincinnati, OH, US

Education

• Bal Vidya Niketan

  C.B.S.E 12th

• Siddaganga Institute of Technology, Tumakuru (SIT Tumkur)

  Bachelor of Engineering (B.E.), Mechanical Engineering

  2011 — 2015

• Pratibha Pallavan Public school

  CBSE; 10th

Skills

• Solid Edge
• Cad
• Catia
• Microsoft Word
• Mechanical Engineering
• Powerpoint
• Microsoft Excel
• C
• Microsoft Office
• Ansys