Quality Engineer II

Job Purpose
Develops and implements engineering solutions to address complaints and product feedback related to manufacturing and non-manufacturing processes, ensuring timely resolution, effective customer communication, regulatory compliance, and continuous improvement of product quality, operational efficiency, and customer satisfaction.

Main Responsibilities:

• Assess processes and products to solve and respond to quality issues.
• Evaluate and implement solutions allowing an optimal Quality Assurance and Preventive Quality.
• Lead the corresponding core teams, to drive initiatives as result of customer complaints.
• Provide technical support for Quality Systems and solve quality issues, often implementing cost-saving measures and high-quality standards.
• Communicate with customers to provide or request information related to their complaints in order to retrieve the necessary details to resolve the issues effectively.
• Provide support for Quality Sustaining Engineering activities when it is required.
• Drive statistical analysis and tools like DOE and Minitab to identify quality issues trends and improve processes.

Required Qualifications:

• Bachelor’s degree in engineering discipline or business sciences.
• 8-10 years in similar position, 5 years in medical company.

Skills & Knowledge:

• Understanding of root cause analysis, statistical analysis, and SPC
• Nonconformance and customer complaint escalation, trend analysis, disposition, investigation, and corrective/preventive actions
• Strong critical thinking and communication skills
• Knowledge and understanding of ISO 13485:2016 requirements and other applicable regulations
• Fluent in spoken and written business English and Spanish

Preferred Qualifications:

• ASQ certified Quality engineer a plus.
• Master Degree in science or medical device fields.
• Six Sigma Tools and Geometric Dimensioning and Tolerancing experience.
• Process validation.