Nitin Pratap

Medical Device Quality Manager with 12+ years of experience in medical device quality assurance, QMS and regulatory compliance. Expertise in CDSCO/MDR 2017, ISO 13485:2016, ISO 14971 risk management, CAPA, internal audits, validation, technical documentation, Device Master Files (DMF), MD-3/MD-7 licensing, cleanroom validation, post-market surveillance (PMS), complaint handling and supplier qualification. Experienced with Class IIa, IIb and III medical devices including dental implants, bone cement and bone fillers.

Quality Manager - RFB Gloves - Noida, India

(2025-10 - 2026-06)

• Spearheaded CDSCO regulatory filings and prepared/submitted applications for Test Licences and Manufacturing Licences (MD-3).
• Developed and executed validation plans and qualification reports for sterilization processes, pouch sealing, AHU systems and manufacturing processes.
• Led internal quality audits, managed non-conformances and executed CAPA to support compliance with ISO 13485:2016.
• Addressed regulatory queries raised by CDSCO inspectors and supported approval workflows.
• Issued Certificates of Analysis (COA) and reviewed Batch Manufacturing Records (BMR) before final batch release.

Sr. Quality Executive - DCL Dencare (I) Pvt. Ltd. - Gurugram, Haryana

(2013-11 - 2025-10)

• Managed quality and regulatory documentation under MDR 2017 for Class IIa, IIb and III medical devices including dental implants, bone cement and bone fillers.
• Implemented, maintained and audited the ISO 13485:2016 Quality Management System across manufacturing processes.
• Coordinated external certified laboratories for biocompatibility studies, sterility testing, water analysis and environmental monitoring.
• Prepared and submitted active Post-Market Surveillance (PMS) reports to CDSCO India and managed customer complaint documentation.
• Managed calibration schedules for laboratory and cleanroom equipment, cleanroom hygiene, equipment CIP and pest-control monitoring.
• Drafted, reviewed and authorized SOPs, inspection checklists, volumetric standard solutions and label approvals.

Lab Chemist – Quality Control - Barmalt (I) Pvt. Ltd. - Gurugram, Haryana

(2011-07 - 2013-11)

• Conducted physical and chemical analysis of raw materials, barley, malt extract, husk, coal and finished goods against BIS and internal specifications.
• Operated, calibrated and maintained UV-VIS Spectrophotometer, Bomb Calorimeter, Viscometer, pH meters and analytical balances.
• Conducted water quality analysis including pH, hardness, alkalinity, TDS, COD and BOD according to BIS standards.
• Maintained quality records and analytical worksheets in compliance with ISO 9001, ISO 22000, FSSC 22000 and HACCP requirements.
• Executed raw-material and packaging-material release systems following FIFO protocols.

M.Sc. - Chemistry - Eillim University (2012)

B.Sc. - Chemistry, Botany & Zoology - Agra University (2008)