Headline

Quality Engineer

About

• Supplier quality engineer with experience for a new class III medical device (Percutaneous Heart Pump). Currently Supporting supplier quality function for R&D projects at the Abbott Temecula site. • Manufacturing/Quality Engineer with proficiency and diverse experience in process improvements, equipment/process validation, supplier process validation (learning) and root cause analysis for coronary, peripheral and neuro-endovascular medical devices. • Comprehensive and detailed experience conducting IQ/OQ/PQ on equipment, performing CAPAs, root cause analysis (5-Why, Fault tree, 6M), updating MPIs and protocol/report writing. • Experience with equipment/process validations • Experience in ISO 14971 (Risk Analysis), ISO 13485 (Quality management systems), FMEAs, DMAIC, statistical DOE, job plans, tool design, qualification and data analysis. • Lean six sigma green belt certified

Location

Sunnyvale

AI stack

claude code

claude

gemini

github copilot

notion

Zapier

Work experience

Relationship Manager at ICICI Bank, Jun 2025 - Jul 2026 · 1 y 1 mo, Bengaluru

Human Resources Assistant at Amazon, Apr 2022 - Jan 2023 · 9 mo, Hyderabad

Education

MBA, General, Indian Institute of Management Sambalpur

B Tech, Mechanical Engineering, College of Engineering Muttathara