Quality Engineer II: Validation, DOE & Process Optimization

Medial Group; Ponce (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Medial Group in Ponce, Puerto Rico is seeking a Quality Engineer II to support validation, qualification, quality assurance, and continuous improvement in a regulated manufacturing environment.

The ideal candidate has hands-on IQ/OQ/PQ, Process Characterization, DOE, TMV, IMV, and Minitab proficiency, plus strong documentation and cross-functional collaboration to ensure compliance with quality and regulatory standards.

Qualifications

• Bachelor's degree in Engineering required.
• 2–3 years of experience in Quality Engineering, Validation, Manufacturing Engineering, or related field.
• Experience supporting validation and qualification activities within a manufacturing environment.
• Knowledge of IQ/OQ/PQ protocol development and execution.
• Familiarity with Process Characterization, DOE, TMV, and IMV methodologies.
• Proficiency in Minitab for statistical analysis and data interpretation.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Strong technical writing, documentation, and analytical skills.
• Excellent verbal and written communication skills.
• Bilingual in English and Spanish.

Responsibilities

• Develop, execute, and support validation and qualification activities for manufacturing processes, equipment, test methods, and systems.
• Prepare, execute, and document IQ, OQ, and PQ protocols.
• Support Process Characterization Studies, TMV, and IMV.
• Develop and execute DOE to evaluate process performance and identify improvement opportunities.
• Use Minitab to perform statistical analysis, process capability studies, data trending, and interpretation of validation results.
• Generate, review, and maintain validation protocols, technical reports, and quality documentation.
• Support quality investigations, nonconformance evaluations, root cause analysis, and corrective actions.
• Analyze manufacturing and quality data to identify trends, risks, and opportunities for process optimization.
• Collaborate with Quality, Manufacturing, Engineering, and Operations teams to support project objectives.
• Ensure compliance with quality systems, regulatory requirements, and internal procedures.

Skills

IQ/OQ/PQ

Process Characterization

DOE

TMV

IMV

Minitab

Excel

Word

PowerPoint

Technical writing

Education

Bachelor's Degree in Engineering

Tools

Minitab

Job description

Medial Group in Ponce, Puerto Rico is seeking a Quality Engineer II to support validation, qualification, quality assurance, and continuous improvement in a regulated manufacturing environment.

The ideal candidate has hands-on IQ/OQ/PQ, Process Characterization, DOE, TMV, IMV, and Minitab proficiency, plus strong documentation and cross-functional collaboration to ensure compliance with quality and regulatory standards.