Quality Engineer II – Shift A & B

About the role

We are looking for a Quality Engineer II to support our manufacturing floor on Shift A and B. The role ensures that all production processes meet the Quality Management System and customer specifications, contributing to the delivery of safe and reliable medical devices.

Key responsibilities

• Coordinate with inspectors to meet on‑time delivery and revenue compliance requirements.
• Verify that production follows quality regulations, product specifications, and customer requirements.
• Lead investigations of non‑conforming material, deviations and manufacturing defects using structured problem‑solving tools (5 Whys, Fishbone, PFMEA) and drive corrective actions.
• Facilitate core‑team meetings, cross‑functional communications and escalations with internal and external stakeholders.
• Promote and manage improvement projects that increase efficiency, preventive quality and continuous improvement.
• Support Quality Engineering initiatives such as SPC, preventive quality and provide technical assistance to maintain high standards.
• Apply statistical tools (DOE, Minitab) to analyse trends, identify quality issues and optimise processes.
• Generate and monitor quality metrics for scorecards, KPIs and management reviews.

Required profile

• Bachelor’s degree in Engineering, Business Administration or related field.
• 3–5 years of experience providing quality support to manufacturing lines.
• Fluent written and spoken Business English and Spanish.
• Strong teamwork and communication skills with internal and external stakeholders.

Required skills

• Proficiency with ERP systems, especially SAP.
• Root‑cause analysis and CAPA (Corrective and Preventive Action) implementation.
• Statistical analysis tools such as DOE and Minitab.
• Experience with SPC, quality scorecards, KPI tracking and QMS tools.