Abhijeet Govind
Quality Engineer || Medical Device R&D || Clinical Research || M.Eng Biomedical Engineering @ Cornell || Certified Six Sigma Black Belt Engineer
- Role
- Quality Assurance and Regulatory Affairs Intern at Caretech Human
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Abhijeet Govind
My fascination with drugs and medical devices began with a routine binge watch of House…
Experience
Quality Assurance and Regulatory Affairs Intern
Jan 2025 — Present · Ithaca, NY, US
Leading the development of risk management documentation for the UroWell device in compliance with ISO 14971 and FDA 21 CFR 820, ensuring thorough identification, assessment, and mitigation of potential risks Designing a Risk Analysis Matrix and utilizing Failure Mode and Effects Analysis (FMEA) to identify failure modes, integrating Preliminary Hazard Analysis (PHA) and Hazard Analysis and Critical Control Points (HACCP) documentation, ensuring the device is fully compliant with ISO 14971 standards Developing Corrective and Preventive Action (CAPA) documentation utilizing root cause analysis tools (5 whys, Fishbone Diagrams) to identify, address and mitigate nonconformities and improve medical device safety, quality and compliance in accordance with ISO 13485 for medical QMS Documented design changes and technical updates in the Design History File (DHF) based on identified risks and usability challenges, ensuring it remained audit ready and complaint with ISO 13485 AND ISO 14971 Authored and managed controlled documents (SOPs, risk files) while assisting in Change Control and Design Control documentation to support audits and inspections. Collaborated in design control activities for the UroWell device, including documenting design inputs and outputs, reviewing risks and ensuring traceability to risk mitigations Utilized tools such as Jira, Confluence, Coda and Microsoft Excel to develop risk analysis templates and streamline documentation processes for full traceability and efficient monitoring of CAPAs and risks. Collaborating in regulatory submissions and documentation to support product approval and compliance
Education
National Institute of Technology Rourkela
Bachelor of Technology - BTech, Biomedical/Medical Engineering
2020 — 2024
M.E.S Indian School,Doha-Qatar
AISSE
Cornell University
Master of Engineering - MEng, Biomedical engineering
M.E.S Indian School,Doha-Qatar
AISSCE, PCMB
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