Quality Engineer II in Nānakrāmguda, भारत

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