Bilingual Quality Engineer — Validation & Compliance

FITS LLC; Ponce (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

FITS LLC in Puerto Rico seeks an Engineering Quality professional to execute validation protocols and support cross-functional teams. The role emphasizes IQ/OQ/PQ execution, DOE studies, and data analysis using Minitab in a regulated manufacturing context.

Ideal candidates hold a Bachelor's in Engineering, 2–3 years of related experience, and are bilingual in English and Spanish. The position is on-site with administrative shift expectations.

Qualifications

• Bachelor's degree in Engineering and 2–3 years of experience in engineering, validation, quality, manufacturing, or related technical field.
• Experience in a regulated environment (Medical Device, Pharmaceutical, Biotechnology, or similar) preferred.
• Fluent in English and Spanish.

Responsibilities

• Execute validation protocols, assist with statistical analysis, prepare technical documentation, and collaborate with cross-functional teams to ensure compliance with quality and regulatory requirements.
• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Develop and execute IQ, OQ, PQ studies, process characterization, TMV, IMV, and DOE.
• Generate and review validation protocols, reports, and technical documentation.
• Utilize Minitab for statistical analysis, process capability studies, data trending, and DOE analysis.
• Support investigations, nonconformance evaluations, corrective actions, and process improvement initiatives.
• Analyze manufacturing and quality data to identify trends and opportunities for improvement.
• Collaborate with Engineering, Quality, Manufacturing, and Operations personnel to support project objectives.
• Ensure all activities are completed in compliance with applicable quality system and regulatory requirements.

Skills

Bilingual (English/Spanish)

Communication skills

Education

Bachelor's degree in Engineering

Tools

Excel

Word

PowerPoint

Minitab

Microsoft Project

IQ/OQ/PQ Protocols

DOE Methodology

TMV/IMV

Job description

FITS LLC in Puerto Rico seeks an Engineering Quality professional to execute validation protocols and support cross-functional teams. The role emphasizes IQ/OQ/PQ execution, DOE studies, and data analysis using Minitab in a regulated manufacturing context.

Ideal candidates hold a Bachelor's in Engineering, 2–3 years of related experience, and are bilingual in English and Spanish. The position is on-site with administrative shift expectations.