Quality Engineer II: Validation & Process Improvement

ECHO Consulting Group Inc; Villalba (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

ECHO Consulting Group, Inc. seeks a Contingent Engineer II to support validation, qualification, and process improvement in a regulated manufacturing environment in Ponce, PR.

You will execute IQ/OQ/PQ protocols, perform DOE analyses with Minitab, and prepare technical documentation while collaborating with cross‑functional teams to ensure compliance with quality and regulatory requirements. The role requires a Bachelor’s degree in Engineering, strong technical writing and communication skills,

Qualifications

• Bachelor’s degree in Engineering required.
• Experience in medical device manufacturing preferred.
• Knowledge of FDA, GMP, and ISO 13485 requirements welcome.

Responsibilities

• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Develop and execute IQ, OQ, PQ, DOE, Process Characterization Studies, TMV and IMV.
• 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 to support project objectives.
• Ensure all activities comply with quality systems and regulatory requirements.

Skills

MS Office proficiency

Excel

Word

PowerPoint

Minitab

Microsoft Project

Technical writing

Verbal communication

Bilingual EN/ES

IQ/OQ/PQ knowledge

Process characterization

DOE methodology

TMV/IMV knowledge

Data interpretation

Education

Bachelor’s degree in Engineering

Tools

Minitab

Microsoft Project

Excel

Word

PowerPoint

Job description

ECHO Consulting Group, Inc. seeks a Contingent Engineer II to support validation, qualification, and process improvement in a regulated manufacturing environment in Ponce, PR.

You will execute IQ/OQ/PQ protocols, perform DOE analyses with Minitab, and prepare technical documentation while collaborating with cross‑functional teams to ensure compliance with quality and regulatory requirements. The role requires a Bachelor’s degree in Engineering, strong technical writing and communication skills,