Quality Engineer II

About the role

The Quality Engineer II will strengthen and expand quality assurance for medical devices by improving existing processes and creating new ones. You will work closely with core teams, customers, and internal stakeholders to resolve quality issues and drive continuous improvement.

Key responsibilities

• Assess processes and products to identify and solve quality issues.
• Lead core teams to implement corrective and preventive actions stemming from customer complaints.
• Provide technical support for quality systems and sustain engineering activities.
• Communicate with customers to gather necessary information for effective issue resolution.
• Conduct statistical analysis, design of experiments (DOE), and use tools such as Minitab to detect trends and improve processes.

Required profile

• Bachelor’s degree in engineering or business sciences.
• 3‑5 years of experience in a similar role, with 2‑3 years in a medical‑device environment.
• Strong critical‑thinking and communication abilities.
• Intermediate proficiency in English and Spanish (verbal and written).

Required skills

• Root cause analysis
• Statistical analysis
• Statistical Process Control (SPC)
• Lean tools
• ISO 13485:2016 knowledge
• Six Sigma methodology
• Geometric Dimensioning and Tolerancing (GD&T)
• Design of Experiments (DOE)
• Minitab