Quality Engineer II

Weil Group • Ponce, PR

5d

About The Position

The Contingent Engineer II supports validation, qualification, and process improvement activities in a regulated manufacturing environment. The role executes validation protocols, assists with statistical analysis, prepares technical documentation, and collaborates with cross-functional teams to help ensure compliance with quality and regulatory requirements.

The position includes validation and qualification work for equipment, processes, test methods, and manufacturing systems, including IQ/OQ/PQ, process characterization studies, test method validation, inspection method validation, and design of experiments. The engineer generates and reviews validation protocols, reports, and other technical documentation; uses Minitab for statistical analysis and data interpretation; supports investigations and corrective actions; and analyzes manufacturing and quality data to identify trends and improvement opportunities.

Requirements

• Bachelor's degree in Engineering.
• 2 to 3 years of experience in engineering, validation, quality, manufacturing, or a related technical field.
• Fully bilingual in English and Spanish, written and spoken.
• Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint.
• Strong technical writing and documentation skills.
• Strong verbal communication skills.
• Working knowledge of IQ/OQ/PQ protocol development and execution, process characterization, DOE methodology, test method validation, and inspection method validation.
• Proficiency in Minitab for statistical analysis and data interpretation.

Nice To Haves

• Experience in a regulated environment such as medical device, pharmaceutical, or biotechnology; listed as preferred under experience.
• Experience in medical device manufacturing.
• Knowledge of FDA, GMP, and ISO 13485 requirements.
• Familiarity with risk management tools such as FMEA and risk assessments.
• Microsoft Project; listed as preferred.

Responsibilities

• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Develop and execute IQ, OQ, and PQ activities, process characterization studies, test method validation, inspection method validation, and design of experiments.
• 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

• Career Level: Mid Level