Senior Quality Engineer — GMP Validation & Compliance Leader

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

Quality Consulting Group, LLC seeks a highly motivated quality professional to lead validation and QA activities in a world‑class manufacturing environment across Puerto Rico and the USA.

The role focuses on equipment and process validation, quality systems, regulatory compliance and change control, with an emphasis on GMP and ISO 13485 standards. Requires 4+ years of experience and a engineering degree.

Qualifications

• Bachelor's degree in engineering.
• 4+ years of experience in related area.
• Expertise in developing, reviewing, approving and executing validation strategies and deliverables for equipment qualification (IQ/CSV/OQ/PQ), decommissioning, process validation, cleaning validation, and cleanroom qualification in GMP environments.
• Strong knowledge of QMS including change control, risk management, nonconformance investigations, and assessment of quality impact from changes.
• Experience evaluating regulatory impact of facility modifications, equipment relocations and process changes to FDA, ISO 13485 and global requirements.
• Strong expertise in IQ/OQ/PQ validation including requalification for new or relocated equipment.
• Experience supporting equipment purchases, relocations and decommissioning with full quality and compliance oversight.
• Audit-ready documentation and regulatory compliance experience.
• Availability for 1st shift.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs inspection and testing mechanisms; conducts QA tests; performs statistical analysis to assess costs and responsibilities for nonconforming materials.
• Ensures corrective actions meet reliability standards and documentation complies with requirements.
• Specializes in design, incoming material, production control, product evaluation and reliability, inventory control and R&D as they apply to product or process quality.
• Equipment & Process Validation
• Quality Systems & Change Control
• Regulatory Compliance & Manufacturing Change Management

Skills

Quality management

Regulatory compliance

Validation strategies

Cross-functional collaboration

Risk management

Education

Bachelor's degree in engineering

Job description

Quality Consulting Group, LLC seeks a highly motivated quality professional to lead validation and QA activities in a world‑class manufacturing environment across Puerto Rico and the USA.

The role focuses on equipment and process validation, quality systems, regulatory compliance and change control, with an emphasis on GMP and ISO 13485 standards. Requires 4+ years of experience and a engineering degree.