Quality Engineer II (Shift B)

About the role

The Quality Engineer II (Shift B) ensures that quality process regulations comply with the Quality Management System on the production floor so that customer standards are met in the manufacturing process. The role covers coordination with inspectors, investigations of nonconformities, improvement projects and statistical quality tools.

Key responsibilities

• Coordinate with inspectors on shipment requirements for OTD and revenue compliance.
• Ensure compliance with quality regulations, product manufacturing and customer specifications.
• Lead investigations of nonconforming material, deviations and manufacturing defects using structured tools such as 5 Whys, Fishbone and PFMEA, and drive corrective actions.
• Lead core team meetings, working groups and cross-functional escalations with internal and external stakeholders, including customers.
• Promote and lead improvement projects to increase efficiency, preventive quality and continuous improvement.
• Support Quality Engineering initiatives to improve QMS tools such as SPC, problem-solving and preventive quality.
• Drive statistical analysis with tools such as DOE and Minitab to identify quality trends and improve processes.
• Perform metrics for the Quality Scorecard, KPIs and management review.

Required profile

• Bachelor's degree in Engineering or Business Administration.
• 3-5 years of experience supporting manufacturing lines; 3+ years in the medical devices industry preferred.
• Demonstrated experience in root cause analysis, corrective and preventive action plans and their implementation.
• Fluent spoken and written Business English and Spanish.
• Experience with complex assemblies (e.g. EP catheters, deflection mechanisms, electrode and sensor integration, multi-component catheter shafts).
• Teamwork, attention to detail and good communication with internal and external stakeholders.

Required skills

• Proficiency with ERP systems such as SAP.
• Knowledge of statistical and quality tools: Minitab, DOE, SPC, ANOVA, problem-solving.
• Process/equipment validation experience is a plus.
• Certification on ISO 13485:2016 and/or 9001:2015 is a nice-to-have.