Quality Engineer II (Shift A & B)

Cartago, Cartago Province, Costa Rica

• Category: Quality Engineering

Description

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Job Purposes

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.

Major Responsibilities:

• 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.

Required Qualifications:

• Bachelor’s degree with an Engineering or Business Administration grade. 
• 3-5 years of experience in Quality providing support to manufacturing lines.

Skills & Knowledge:

• 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. 

Preferred Qualifications:

• +3 years at medical devices industry.
• Certified on ISO 13485:2016 and/or 9001:2015 standards.  

Company

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Heraeus

Heraeus, the technology group headquartered in Hanau, Germany, is a leading international family-owned company formed in 1851. With expertise, a focus on innovations, operational excellence and an entrepreneurial leadership, we strive to continuously improve our business performance. We create high-quality solutions for our clients and strengthen their competitiveness in the long term by combining material expertise with technological know-how. 

Our ideas are focused on themes such as the environment, energy, health, mobility and industrial applications. Our portfolio ranges from components to coordinated material systems which are used in a wide variety of industries, including the steel, electronics, chemical, automotive and telecommunications industries. In the 2014 financial year, Heraeus generated product revenues of €3.4 bn and precious metal revenues of €12.2bn euros. 

With around 12,600 employees worldwide in more than 100 subsidiaries in 38 countries, Heraeus holds a leading position in its global markets.