Quality Engineer II

Quality Engineer II

Heraeus Medevio

Location Cartago

Permanent

Full Time

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.