Quality Validation Engineer II - Medical Device (IQ/OQ/PQ)

ECHO Consulting Group; Puerto Rico; On-site; USD 70,000 - 100,000; Full time

Job summary

ECHO Consulting Group seeks a Contingent Engineer II to support validation, qualification, and process improvements in a regulated manufacturing setting. You will execute validation protocols, assist with statistical analysis, and prepare technical documentation while collaborating with cross-functional teams to ensure compliance with quality and regulatory requirements.

Responsibilities include IQ/OQ/PQ, DOE, TMV, IMV, data trending, and investigations.

Qualifications

• Bachelor’s degree in Engineering.
• 2–3 years of experience in validated environments.
• Experience in medical device manufacturing.
• Knowledge of FDA, GMP, 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.
• Develop and execute IQ, OQ, PQ, DOE, TMV, IMV activities.
• Generate and review validation protocols, reports, and technical documentation.
• Utilize Minitab for statistical analysis, process capability, data trending, and DOE.
• Support investigations, nonconformances, corrective actions, and process improvements.
• Analyze manufacturing and quality data to identify trends and opportunities for improvement.
• Collaborate with Engineering, Quality, Manufacturing, and Operations to meet project objectives.
• Ensure activities comply with quality systems and regulatory requirements.

Skills

Microsoft Office Suite

Technical writing

Verbal communication

Bilingual EN/ES

Education

Engineering degree

Tools

Minitab

Job description

ECHO Consulting Group seeks a Contingent Engineer II to support validation, qualification, and process improvements in a regulated manufacturing setting. You will execute validation protocols, assist with statistical analysis, and prepare technical documentation while collaborating with cross-functional teams to ensure compliance with quality and regulatory requirements.

Responsibilities include IQ/OQ/PQ, DOE, TMV, IMV, data trending, and investigations.