Senior Quality Validation Engineer – GMP & Regulatory

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group is seeking a talented professional to join our team in Puerto Rico & USA. The role focuses on developing, validating and maintaining quality standards for manufacturing processes and materials.

You will collaborate across engineering, manufacturing and quality to ensure robust QA systems and regulatory compliance. Responsibilities include designing inspection mechanisms, implementing testing protocols, and ensuring audit-ready documentation in GMP-regulated environments.

Qualifications

• 4+ years of experience in quality or validation roles.
• Expertise in developing, reviewing, approving and executing validation strategies and deliverables (IQ/CSV/OQ/PQ).
• Strong knowledge of QMS, change control and risk management.
• Experience with FDA, ISO 13485 and global regulatory requirements.

Responsibilities

• Develop and maintain quality standards and protocols for materials processing to finished products.
• Collaborate with engineering and manufacturing to ensure quality controls are in place.
• Design and implement inspection and testing strategies; perform statistical analysis on products and processes.
• Ensure documentation and records are audit-ready and compliant with requirements.
• Support equipment validation and change control activities, including IQ/OQ/PQ and requalification.

Skills

Validation strategies

Quality systems

Regulatory compliance

GMP environments

Equipment qualification

Documentation quality

Job description

Quality Consulting Group is seeking a talented professional to join our team in Puerto Rico & USA. The role focuses on developing, validating and maintaining quality standards for manufacturing processes and materials.

You will collaborate across engineering, manufacturing and quality to ensure robust QA systems and regulatory compliance. Responsibilities include designing inspection mechanisms, implementing testing protocols, and ensuring audit-ready documentation in GMP-regulated environments.