Quality Engineer

Flexible & Integrated Technical Services, LLC; Ponce (PR); Presencial; USD 60.000 - 90.000; Jornada completa

Descripción de la vacante

FITS LLC in the Manufacturing/Engineering sector is seeking an Engineering Quality professional to execute validation protocols, develop IQ/OQ/PQ, and perform DOE studies within a regulated environment.

The role requires strong statistical skills and cross-functional collaboration in a compliance-focused setting.

Formación

• Bachelor's degree in Engineering with 2–3 years of experience in engineering, validation, quality, manufacturing.
• Experience in regulated environments (Medical Device, Pharmaceutical, Biotechnology) preferred.
• Bilingual in English and Spanish.
• Shift: Administrative and per business needs.
• Experience with IQ/OQ/PQ, DOE, TMV, IMV, and statistical data interpretation with Minitab.

Responsabilidades

• Execute validation protocols and support statistical analyses.
• Perform IQ/OQ/PQ studies and process characterization.
• Execute DOE studies and related qualification activities.
• Generate and review validation protocols, reports, and technical documentation.
• Utilize Minitab for statistical analysis, process capability studies, data trends, and DOE analysis.
• Support investigations, nonconformance evaluations, corrective actions, and process improvements.
• Analyze manufacturing and quality data to identify trends and opportunities for improvement.
• Collaborate with Engineering, Quality, Manufacturing, and Operations to support project objectives.
• Ensure activities comply with quality systems and regulatory requirements.

Conocimientos

Bilingual English/Spanish

IQ/OQ/PQ Protocol Development

DOE Methodology

TMV

IMV

FMEA/Risk Assessments

Statistical Analysis

Educación

Bachelor's degree in Engineering

Herramientas

Microsoft Office Suite

Minitab

Microsoft Project

Descripción del empleo

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?