Quality Engineer

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

For Engineering Quality services in the Manufacturing/Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's degree in Engineeringand a minimum of two to three (2-3)years of experience in engineering, validation, quality, manufacturing, or a related technical field.
• Experience within a regulated environment (Medical Device, Pharmaceutical, Biotechnology, or similar) preferred.
• Bilingual (English & Spanish).
• Shift: Administrative and according to business needs
• Experience in:
  • Proficiency in Microsoft Office Suite: Excel, Word, Power Point, Microsoft Project.
  • IQ/OQ/PQ Protocol Development and Execution.
  • Process Characterization.
  • DOE Methodology.
  • Test Method Validation (TMV).
  • Inspection Method Validation (IMV).
  • Proficiency in Minitab for statistical analysis and data interpretation.
  • Knowledge of FDA, GMP, and ISO 13485 requirements.
  • Familiarity with risk management tools (FMEA, risk assessments).

The Personality Part:

• If you have excellent communication skills and aren’t afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you! Sprinkle on a love of the scientific method, teamwork, and, above all else, being ethical, and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS, YOU WILL:

• Responsible for executing validation protocols, assisting with statistical analysis, preparing technical documentation, and collaborating 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.
• Development and execution of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Characterization Studies, Test Method Validation (TMV), Inspection Method Validation (IMV), Design of Experiments (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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the next piece?