Senior Quality Engineer – GMP & Validation Expert

qualityconsultinggroup; Juncos (PR); On-site; USD 90,000 - 125,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented QA/Validation professional to join our team in a world-class manufacturing environment serving Puerto Rico and the USA. You will develop and maintain quality standards, collaborate with engineering and manufacturing, and design inspection systems for precision testing.

Role requires 4+ years in quality/validation, expertise in IQ/OQ/PQ in GMP settings, and strong QMS/change-control knowledge, with readiness for 1st shift and regulatory liaison

Qualifications

• Bachelor's degree in engineering required.
• 4+ years of related quality/validation experience.
• Expertise in equipment and process validation (IQ/OQ/PQ) in GMP environments.
• Strong knowledge of QMS, change control and risk management.
• Experience with FDA/ISO 13485 regulatory requirements.
• Ability to work 1st shift.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into finished materials.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating products and equipment.
• Designs inspection and testing mechanisms; conducts QA tests and statistical analysis.
• Ensures corrective measures meet reliability standards and documentation is compliant.
• Specializes in areas like design, incoming material, production control, or R&D as they apply to quality.
• Oversees equipment & process validation, change control, regulatory compliance.

Skills

Quality management

Quality assurance

GMP compliance

Regulatory compliance

Risk assessment

Education

Bachelor's degree in engineering

Tools

QMS systems

Job description

QUALITY CONSULTING GROUP, LLC is seeking a talented QA/Validation professional to join our team in a world-class manufacturing environment serving Puerto Rico and the USA. You will develop and maintain quality standards, collaborate with engineering and manufacturing, and design inspection systems for precision testing.

Role requires 4+ years in quality/validation, expertise in IQ/OQ/PQ in GMP settings, and strong QMS/change-control knowledge, with readiness for 1st shift and regulatory liaison