Nandu Kishore Email & Phone Number

As someone who has worked in the medical device industry for many years, I have developed a deep understanding of the industry's many facets, including Design Quality, Process Validation, Research and Development, and Quality Engineering. My expertise is broad, but my specific focus is on Product and Process validation and verification, Risk Management, and Quality Control.One area where I truly excel is working with EU-MDR DHF Deliverables. I have led or supported EU MDR DHF updates and remediations, ensuring that project Design and Development Plans align with Risk Management Plan/Regulatory Plan requirements, as stipulated by compliance with QSR (21 CFR 820) / (ISO 13485) ISO 14971)/IECs: 60601-1, 62304, 62366-1, and 62366-2.I have extensive experience creating, reviewing, and approving engineering test protocols and reports in support of design verification, design validation, and process validation. I have also developed and maintained design verification test equipment labs, including test systems for verifying product performance to electrical and mechanical safety testing. My knowledge of FMEA, DFMEA, PFMEA, Gage Reproducibility and repeatability studies (Gage R&R), and authoring and executing process and equipment validations (IQ/OQ/PQ) for assembly and packaging areas is unparalleled.I am also adept at implementing 5S and conducting continuous improvement projects, including SIX SIGMA, KAIZEN, and 5S. I provide process/quality engineering support to assess risk, address gaps in compliance, and re-validate equipment and processes within the scope of remediation. My extensive knowledge of complex manufacturing processes enables me to address issues related to Process development, Corrective Actions Preventive Actions (CAPAs), Nonconformance Material Reports (NCMRs), and performing Root Cause Analysis (RCA). I am also well-versed in MINITAB, Design Requirements/Flowdown, and Cognition Cockpit.In my current role as a Design Assurance Engineer at Integra Life Sciences, I lead EU-MDR Remediation activities for IEC-60601 Electro-Mechanical Products, developing European Medical Device Regulation (EU MDR) Technical Files and conducting gap assessments on existing Technical Files/Design Dossiers against Medical Device Reporting requirements.With my MS in Industrial Engineering, along with my Six Sigma and Total Quality Management Green Belt certifications, I am confident in my ability to contribute to any project, team, or organization with a strong focus on quality, safety, and compliance.