Sai Kiran Kolluru
Senior-Level Quality Engineer | Medical Devices | 510(k) | Design Controls | Risk Management | FDA & ISO 13485
- Role
- Quality Engineer at Medline
- Location
- Arlington Heights, IL, US
- LinkedIn followers
- 500 followers
About Sai Kiran Kolluru
I\'m a Quality Engineer with 8+ years of experience in the medical device industry, operating at the intersection of engineering, regulatory compliance, and business execution. At Medline, I lead quality strategy across product portfolios, driving risk-based remediation initiatives, 510(k) regulatory submissions, and cross-functional design transfer programs. I partner closely with R&D, operations, regulatory, and global suppliers to ensure products move efficiently through development while maintaining strict compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971. Beyond project execution, I’ve led corporate-wide SOP standardization initiatives, managed complex CAPAs and supplier corrective actions, and mentored engineers to elevate team capability. I believe quality should be a strategic enabler — balancing compliance, speed, and innovation without compromising patient safety. Core focus areas: • Design Controls & Risk Management • 510(k) Submissions • CAPA & Supplier Quality • Process Validation (IQ/OQ/PQ) • Audit Readiness & Regulatory Strategy
Experience
Quality Engineer
Oct 2021 — Present
Education
Anna University Chennai
Bachelor's degree, Mechanical Engineering
Northern Illinois University
Master's degree, Industrial and Systems Engineering
2016
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