Quality Engineer 1

This is a full-time position to work Monday to Friday from 8am to 5pm in our Heredia Site, located in Zona Franca Metropolitana. Remote work might be allowed based on business needs. 

Our Quality Engineers 1, provide quality engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier quality management. Support finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology. Participate in or lead Corrective/Preventive Action initiatives. Support internal/ external and suppliers audit, vendor qualification and training programs. Participate in Quality/ Business initiatives including business process improvement activities, documented Quality System re-architecture and other cross-functional projects.

Principal Responsabilities:

• Prepare and update quality documents and any applicable documentation required to sustain the manufacturing process, system or NPI projects, including but not limited to documentation linked to the Device Master Records and Device History Records.
• Execute reviewing / approval of any documentation created / updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
• Support in analysis, review and implementation of new methodologies, processes, tools that contribute to the improvement on the manufacturing process, quality systems or supplier improvements.
• Checks, provides support and executes initiation / investigation for NCs, Complaints, Calibration, SCARs and Environmental Monitoring.
• Provide follow up to actions generated from corrective and preventive plans.
• Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
• Maintain and follow up CAPA and supplier files. (Quality Systems and Supplier Engineer only).
• Support in the execution of qualifications (IQs/OQs/PQs/PPQs/TMVs) with an approved protocol; gather data and analysis results for completing the corresponding report.

Knowledge / Education / Job Experience:

•  Minimum education required to perform duties: Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry).
• From 0 to 1 year work experience in manufacturing environment.
• Bilingual English/Spanish – Basic English level, reading comprehension and writing.
• Basic knowledge and application of statistical techniques (basic descriptive statistics).
• Basic knowledge in root cause analysis tools.
• Knowledge of Minitab statistical software is a plus.

Skills / Competencies: 

• Good interpersonal skills and the ability to communicate orally and in writing.
• Self-motivated.
• Organized and able to manage multiple tasks and priorities.
• Must be able to read and understand specifications. Proficient in the interpretation of technical drawings.
• Must be able to work and effectively communicate with others.
• Highest ethical standards and professional integrity.
• Able to work independently.
• Teamwork oriented.
• Decision making: Must be able to quickly and independently make decisions.
• Proactive
• Discipline
• Customer oriented
• Team player
• Diligent
• Retentive
• Good learner
• Hands-on, collaborative, decisive.
• Must be flexible and adapt to changing environments and priorities.
• Problem Solving: Basic understanding of problem-solving methodology.
• Metrology: Basic knowledge of measurement and error theory and measuring instruments and equipment.