Quality Engineer II

Job Purpose

Ensure and expand quality assurance through the improvement of the current quality processes or creation of new processes.

 

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.
• 3-5 years in similar position, 2-3 years  in medical company.

 

Skills & Knowledge

• Understanding of root cause analysis, statistical analysis, SPC, and Lean tools.
• Nonconformance and customer complaint escalation, trend analysis, disposition, investigation, and corrective/preventive actions.
• Strong critical thinking and communication skills.
• Knowledge of ISO 13485:2016 requirements.
• Intermediate bilingual (English/Spanish) verbal and writing.

 

Preferred Qualifications

• ASQ certified Quality engineer a plus.
• Six Sigma Tools and Geometric Dimensioning and Tolerancing experience.
• Process validation.