Akhil Bhimireddy
Sr. Software Quality Engineer I, Design Assurance at Align Technology
- Role
- Sr Software Quality Engineer i, Design Assurance at Align Technology
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Akhil Bhimireddy
Medical device professional with a history of improving and optimizing quality systems and products. I offer 3+ years of experience working in the medical device industry with demonstrated application of standards and regulatory framework. I have my Master\'s Degree in Biomedical Engineering from The University of Texas at Dallas with Coursework and lab research focused on Commercialization and Development of Medical Devices.Background and Skills: CAPA, DMAIC, Problem Solving, Root Cause Analysis, FMEAs, Device Failure Investigations, ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR 803, 21 CFR 820, EU MDD, EU MDR, Internal and External Audit support, Product and Process Risk Management, Lean Six Sigma, Supplier File Reviews, SCARs, DHF, DMR, Product Technical File Documentation, NCMRs, Complaints Handling, Drafting Protocols, SOPs, QCFs, Traceability Matrix, Post Market Surveillance, Regulatory Responses, Design Controls, and Quality Controls.
Experience
Sr Software Quality Engineer i, Design Assurance
Feb 2025 — Present · San Jose, CA, US
Education
National Institute of Technology Rourkela
Bachelor of Technology, Biomedical Engineering
2013 — 2017
The University of Texas at Dallas
Master's degree, Biomedical/Medical Engineering
2018 — 2020
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