Quality Engineering Associate — Pharma/Med Device

fitspr; Caguas (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

FITS is seeking an Engineering Quality professional in Puerto Rico to support pharmaceutical and medical device projects. The role focuses on developing product quality plans, quality specifications, risk analyses, and cross-site collaboration.

You will write and approve protocols, manage changes, monitor progress against the project plan, and lead investigations and troubleshooting with minimal supervision, while ensuring timely reports and quality improvements.

Qualifications

• Bachelor’s degree in Engineering required.
• Bilingual (English & Spanish) required.
• Project management skills are required.
• Experience in Manufacturing Process, Documentation, Validation Protocols, Investigations, and Troubleshooting.

Responsibilities

• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
• Anticipates potential situations that may impact project timelines and resolves them before they become an issue.
• Is the technical liaison with other cross functional areas with other sites.

Skills

Engineering Degree

Bilingual (English/Spanish)

Project Management

Manufacturing Process

Documentation

Validation Protocols

Investigations

Troubleshooting

Shift Flexibility

Education

Bachelor’s Degree in Engineering

Job description

FITS is seeking an Engineering Quality professional in Puerto Rico to support pharmaceutical and medical device projects. The role focuses on developing product quality plans, quality specifications, risk analyses, and cross-site collaboration.

You will write and approve protocols, manage changes, monitor progress against the project plan, and lead investigations and troubleshooting with minimal supervision, while ensuring timely reports and quality improvements.