Arya Bhatt

WORK HISTORY

EDUCATION

ABOUT ARYA BHATT

Quality professional with hands-on experience in medical devices and combination products. Skilled in supporting R&D and manufacturing activities across design control, risk management, CAPA, and post-market quality. Experienced in complaint handling, DHF documentation, process validation, and design transfer. Worked closely with cross-functional teams, CMOs, and third-party vendors to ensure compliance with FDA, ISO, and internal QMS standards along with continuous improvement of quality systems for products such as pre-filled syringes, auto-injectors, and on-body injectors• Worked on the validation and manufacturing of injectable drug delivery systems auto-injectors, prefilled syringes, and wearable drug delivery systems.• Supported site and project QA activities for R&D programs involving medical devices and combination products• Assisted with third-party management (TPM) activities, including vendor selection, qualification, monitoring, and integration into product development.• Supported the creation of quality agreements, oversight plans, audit coordination, vendor report reviews, and risk scorecards.• Worked with cross-functional R&D and co-development drug teams to provide QA support for multiple MDCP projects, including a major platform launch• Led risk assessments (FMEA, CAPA) and failure investigations for needle-based injection systems (NIS), prefilled syringes, and auto-injectors, ensuring safety and performance consistency.• FDA Infusion Pump Initiative – CAPA effectiveness rating, event code rationalization, and HHE and risk assessment document development led a team of 7 QE to rate and evaluate CAPA’s.• Cross trained to work on every step of the complaint process from entry, decision making, review, MDR filing, investigations and record closure.