Senior Quality Engineer - North Haven, CT

Medtronic seeks a Senior Quality Engineer to support manufacturing operations for surgical sutures at its North Haven facility. The role focuses on process validation, quality system execution, and regulatory compliance within medical device manufacturing, requiring five days per week onsite presence.

Responsibilities

• Lead process validation planning, protocol development, execution, analysis, and ongoing monitoring
• Partner with manufacturing and engineering teams to develop and maintain quality standards and process controls
• Drive root cause investigations, corrective and preventive actions, and nonconforming material activities
• Analyze quality and process performance data using statistical methods for risk-based decision making
• Develop inspection, testing, and evaluation methods to verify product quality and process capability

Requirements

• Bachelor's degree in Engineering or Science with 4+ years relevant experience, or Master's degree with 2+ years experience
• 2+ years executing process validation activities across full validation lifecycle
• Experience in FDA-regulated medical device or pharmaceutical manufacturing environments
• Proficiency with statistical analysis tools such as Minitab
• Knowledge of CFR requirements, engineering drawings, and manufacturing processes including sterilization
• ASQ Certified Quality Engineer, Lean Six Sigma, or equivalent quality certification preferred