bhargavi kannan
@bhargavikannan
Quality Engineer specializing in medical device design controls, software validation, and regulatory-ready documentation.
United StatesWhat I'm looking for
I’m a Quality Engineer with 5+ years supporting Class II and software-enabled medical devices throughout the product lifecycle. I partner with cross-functional teams to deliver compliant, audit-ready documentation in FDA- and ISO 13485-regulated environments.
My work centers on design controls and risk management—translating requirements into actionable deliverables, maintaining end-to-end traceability in the DHF, and leading software verification and validation activities. I lead CAPA/NCR investigations using root cause analysis (FMEA, 5 Whys), improve CAPA closure timelines by ~25%, and reduce defect trends across key product areas by 15–20%.
I also drive quality improvement through data analysis, complaint trending, and post-market surveillance contributions (including support for PSUR and post-market documentation updates). As a Quality representative on cross-functional teams, I help reduce investigation turnaround time by ~20% and support successful FDA/ISO audits with no major findings.
Experience
Work history, roles, and key accomplishments
QA & Regulatory Affairs Intern
Micro Medical Devices
May 2019 - Mar 2020 (10 months)
Developed a comprehensive 510(k) device master record to ensure alignment with FDA requirements and support the regulatory approval process. Managed regulatory and QA initiatives for a portable ophthalmology device across the US and EU, and led CAPA investigations and nonconformance analysis to improve product quality and reliability.
Education
Degrees, certifications, and relevant coursework
University of Southern California
Master of Science in Biomedical Engineering, Biomedical Engineering
Grade: GPA: 3.75/4.0
Earned a Master of Science in Biomedical Engineering with a 3.75/4.0 GPA. Coursework included biomedical systems, physiological control, signals and systems, and quality/regulatory topics for medical devices.
Anna University
Bachelor of Engineering in Biomedical Engineering, Biomedical Engineering
Grade: First Class with distinction; GPA: 8.90/10; Univ. Rank #3
Activities and societies: Full Merit Scholarship (2017–2018) for academic performance.
Earned a Bachelor of Engineering in Biomedical Engineering, graduating First Class with distinction. Received a full merit scholarship and ranked University Rank #3 among Biomedical Engineering students in Tamil Nadu.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
Interested in hiring bhargavi?
You can contact bhargavi and 90k+ other talented remote workers on Himalayas.
Message bhargaviFind your dream job
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
