Quality Engineer II role supporting medical device product development and sustaining engineering at Medtronic's Hyderabad facility. Responsibilities include design quality reviews, regulatory compliance oversight, risk management documentation, and design verification/validation activities across the product lifecycle.
Responsibilities
Review product design documentation for quality characteristics including manufacturability, serviceability, and testability
Ensure compliance with FDA, EU MDR, and internal quality requirements for development projects and design changes
Develop and maintain risk management documentation including Risk Management Plans and Design FMEA per ISO 14971
Support design verification and validation activities through protocol development and compliance assessments
Support product transfer to manufacturing via process validation including PFMEA, IQ, OQ, and PQ activities
Requirements
Bachelor's degree in Mechanical Engineering
5+ years overall experience; 3+ years in medical device or regulated manufacturing quality roles
Experience with design controls, risk management, and ISO 14971 activities
Knowledge of FDA QSR, ISO 13485, EU MDR, IEC 60601, 21 CFR Part 820, and 21 CFR Part 11
Proficiency with statistical tools including Minitab, sampling plans, ANOVA, and GR&R analysis
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