Quality Engineer II — Validation & Process Improvement

ECHO Consulting Group; Villalba (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

ECHO Consulting Group is seeking a Contingent Engineer II to support validation and process improvement in a regulated manufacturing environment in Ponce, PR. The role emphasizes executing validation protocols, statistical analysis with Minitab, and collaboration across cross-functional teams to ensure quality compliance.

Ideal candidates have 2–3 years of experience, a BS in Engineering, and knowledge of FDA, GMP, and ISO 13485 requirements.

Qualifications

• Experience in medical device manufacturing.
• Knowledge of FDA, GMP, and ISO 13485 requirements.
• Familiarity with risk management tools (FMEA, risk assessments).

Responsibilities

• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Development and execution of: 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.

Skills

Strong verbal communication skills

Strong technical writing and docs

Microsoft Office proficiency

Fully bilingual English/Spanish

Education

Bachelor’s degree in Engineering

Tools

Minitab

Job description

ECHO Consulting Group is seeking a Contingent Engineer II to support validation and process improvement in a regulated manufacturing environment in Ponce, PR. The role emphasizes executing validation protocols, statistical analysis with Minitab, and collaboration across cross-functional teams to ensure quality compliance.

Ideal candidates have 2–3 years of experience, a BS in Engineering, and knowledge of FDA, GMP, and ISO 13485 requirements.