Senior Quality Engineer

LivaNova seeks a Senior Quality Engineer to support quality management across product design, manufacturing, and compliance for medical devices. The role involves nonconforming product analysis, failure investigations, design control oversight, complaint evaluation, and process improvements within a regulated medtech environment.

Responsibilities

• Analyze nonconforming product data and make disposition decisions; mentor junior quality engineers
• Lead failure investigations and root cause analysis using systematic problem-solving methods
• Establish quality control plans and coordinate design verification/validation activities
• Evaluate complaint data and returned products; interface with customers on issue resolution
• Support corrective action processes, identify quality improvements, and lead related projects

Requirements

• 6-8 years medical device manufacturing experience, preferably Class II/III devices
• In-depth or broad engineering skills with demonstrated technical proficiency
• Proficiency with quality tools: flowcharts, statistical analysis, mathematical reasoning
• Excellent written and verbal communication and presentation abilities
• Ability to adapt in changing environments and work across organizational levels
• Knowledge of FDA, ISO 13485, MDSAP, and medical device regulatory requirements