Quality Engineer

Flexible & Integrated Technical Services, LLC • Ponce, PR

6d

About The Position

The Quality Engineer provides engineering quality services in the Manufacturing/Engineering area. The role executes validation and qualification activities for equipment, processes, test methods, and manufacturing systems; prepares and reviews technical documentation; performs statistical analysis; and works with cross-functional teams to ensure compliance with quality-system and regulatory requirements. The position has an administrative shift, according to business needs.

Requirements

• Bachelor's degree in Engineering.
• Two to three years of experience in engineering, validation, quality, manufacturing, or a related technical field.
• Bilingual in English and Spanish.
• Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Microsoft Project.
• Experience with IQ/OQ/PQ protocol development and execution.
• Experience with process characterization, DOE methodology, Test Method Validation (TMV), and 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, including FMEA and risk assessments.
• Excellent communication skills, teamwork, ethical conduct, and a willingness to ask for help when needed.

Nice To Haves

• Experience in a regulated environment, such as Medical Device, Pharmaceutical, Biotechnology, or a similar industry.

Responsibilities

• Execute validation protocols and assist with statistical analysis.
• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), process characterization studies, Test Method Validation (TMV), Inspection Method Validation (IMV), and Design of Experiments (DOE).
• Generate and review validation protocols, reports, and technical documentation.
• Use 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 activities comply with applicable quality-system and regulatory requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level