Quality Engineering Technician

Quality Engineering Technician


Job ID: 10468209

Fajardo, PR, US

Engineering

Bachelors Degree

Full Time, Temporary

18

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Fajardo, PR, US

18

Experienced (Non-Manager)

Full Time, Temporary

Biotechnology/Pharmaceuticals

On-site

Engineering

Bachelors Degree

First Shift (Day)

Job details

Job descripton:
The Quality Engineer Technician is responsible for providing technical and administrative support to the Quality Engineering function. This role assists with process monitoring, statistical analysis, performance trending, quality investigations, sampling plan administration, data management, and other activities. The position serves as a key resource in maintaining process control programs, supporting quality systems, and ensuring accurate, timely, and compliant execution of Quality Engineering activities.

This position reports to the Sr. Quality Assurance Manager and is part of the Quality Assurance Department located in Fajardo, Puerto Rico and will be an on-site role. 

What you will do:

  • Provide technical support to Quality Engineers by collecting, analyzing, and maintaining manufacturing and quality data to support process monitoring, trending, and decision-making activities.

  • Generate and maintain statistical reports, control charts, dashboards, and performance metrics using approved tools to support ongoing process control and identification of trends, shifts, and variability.

  • Support quality investigations by gathering data, compiling evidence, maintaining documentation, tracking corrective actions, and assisting with root cause analysis and effectiveness review activities.

  • Maintain controlled quality and engineering records, support document revisions, change controls, procedure updates, training deployment, and ensure documentation remains accurate, traceable and audit ready.

  • Partner with Manufacturing, Engineering, Operations, and Quality Teams to track action items, support continuous improvement initiatives, assist with project execution, and enhance data management, reporting, and process monitoring systems.

Who you are:

  • Bachelor Degree in Engineering, Science, or related field preferred.

  • 4+ years of experience in Quality, Engineering, Manufacturing or a regulated industry environment.

  • Experience working with technical data analysis and process monitoring preferred.

  • Experience in FDA, ISO 13485, GMP, or regulated manufacturing environments preferred.

 

10468209

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