Quality Engineer

Abbott seeks a Quality Engineer to support the Structural Heart medical devices business in Puerto Rico. The role involves process and quality engineering for manufacturing operations, ensuring product compliance and addressing quality issues through root cause analysis and corrective actions.

Responsibilities

• Identify and disposition manufacturing defects, nonconforming material, and customer complaints
• Lead root cause investigations and implement corrective and preventive actions
• Own exception and CAPA activities with support for product containment and release criteria
• Develop and maintain product quality plans, risk analyses, and FMEAs
• Drive product and process improvement efforts using quality data and six sigma methodologies

Requirements

• Bachelor's degree in Engineering
• Minimum 2 years quality and/or compliance experience, preferably medical devices
• Knowledge of US and non-US applicable regulations
• Proficiency in quality engineering principles and applications
• Fluency in English and Spanish, written and verbal
• Cross-functional communication and interpersonal skills
• Microsoft Office and general digital competency