Senior Quality Engineer – Validation & Compliance

Echo-Consulting-Group; Puerto Rico; On-site; USD 60,000 - 90,000; Full time

Job summary

Echo Consulting Group is seeking a seasoned professional in quality assurance and validation for challenging roles in pharmaceutical, biotech and medical device environments. The role emphasizes IQ/OQ/PQ validation, GMP compliance, and cross-functional collaboration to deliver compliant, reliable processes.

The position requires an engineering degree and experience in regulated manufacturing. You will work with Manufacturing, Engineering and QA to ensure quality from design through

Qualifications

• Bachelor's in Engineering or equivalent technical degree.
• Strong expertise in equipment and process validation (IQ/OQ/PQ).
• Knowledge of GMP and regulatory compliance in manufacturing.
• Experience supporting validation documentation and change controls.
• Ability to collaborate across Manufacturing, Engineering and QA teams.

Responsibilities

• Develops, modifies, applies and maintains quality standards.
• Collaborates with engineering and manufacturing to ensure quality standards.
• Develops and implements methods for inspecting, testing and evaluating products and production equipment.
• Performs statistical analysis and ensures documentation is compliant.
• May specialize in design, production control, product evaluation and reliability.

Skills

Quality Assurance

IQ/OQ/PQ

GMP knowledge

Regulatory compliance

Project management

Education

Bachelor's in Engineering

Job description

Echo Consulting Group is seeking a seasoned professional in quality assurance and validation for challenging roles in pharmaceutical, biotech and medical device environments. The role emphasizes IQ/OQ/PQ validation, GMP compliance, and cross-functional collaboration to deliver compliant, reliable processes.

The position requires an engineering degree and experience in regulated manufacturing. You will work with Manufacturing, Engineering and QA to ensure quality from design through