Ensuring Quality process regulations are in compliance with the Quality Management System in the production floor in order to meet customer standards in the manufacturing process.
Coordinate with the inspectors on shipment requirements for OTD and Revenue compliance.
Ensure compliance with Quality regulations, product manufacturing, and customer specifications when manufacturing product.
Lead investigations related to nonconforming material, deviations, and manufacturing defects using structured problem-solving tools (e.g., 5 Whys, Fishbone, PFMEA) to identify root cause and implement effective corrective actions.
Lead core team meetings, working groups, and cross-functional communication and/or escalations with internal and external stakeholders (including customers), defining and driving corrective actions to ensure compliance with product specifications.
Promote and lead improvement projects to increase efficiency, preventive quality and continuous improvement of the area.
Support Quality Engineering initiatives to improve QMS tools such as SPC, Problem-Solving, Preventive Quality, providing technical support to get high-quality standards.
Drive statistical analysis and tools like DOE and Minitab to identify quality issues trends and improve processes.
Perform metrics corresponding to Quality Score Card Process, KPI and Management Review.

Bachelor’s degree with an Engineering or Business Administration grade.
3-5 years of experience in Quality providing support to manufacturing lines.
Proficient in using in ERP systems like SAP.
Demonstrated experience in root cause analysis, corrective and preventive action plan and implementation.
Fluent in spoken and written Business English and Spanish.
Teamwork with other departments and good communication with internal and external stakeholders.
Knowledge of troubleshooting tools.
Good personal relationships.
Attention to details.
Proven experience working with complex assemblies (e.g. EP catheters, deflection mechanisms, electrode and sensor integration, multi-component catheter shafts, etc.).
Experience in process/equipment validation.
Knowledge of statistical and Quality tools as Minitab, DOE, SPC, ANOVA, Problem-Solving, among others.

Quality Engineer II

Key skills