Senior Quality Engineer - GMP/ISO Compliance & Validation

qualityconsultinggroup; Humacao (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QUALITY CONSULTING GROUP is seeking a highly motivated quality professional to join our team in the pharmaceutical, biotech, medical devices, and manufacturing sectors across Puerto Rico and the USA.

The role focuses on developing and maintaining quality standards, collaborating with engineering and manufacturing, and applying robust validation and testing to ensure compliant products and processes. Strong analytical and problem-solving skills are essential.

Qualifications

• Experience in FDA/ISO-regulated manufacturing environments, including GMP.
• Knowledge of validation and manufacturing processes (IQ/OQ/PQ) and risk management.
• Proficiency in problem-solving, risk assessment, and data analysis tools (FMEA, 5 Whys, SPC, DOE).
• Strong communication and collaboration skills; Lean Six Sigma preferred.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions 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 or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Equipment & Process Validation
• Quality Systems & Change Control
• Regulatory Compliance & Manufacturing Change Management

Skills

Problem solving

Risk assessment

Data analysis

Lean Six Sigma

Communication

Collaboration

Education

Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field

Tools

Minitab

JMP

Excel

Power BI

SAP

Job description

QUALITY CONSULTING GROUP is seeking a highly motivated quality professional to join our team in the pharmaceutical, biotech, medical devices, and manufacturing sectors across Puerto Rico and the USA.

The role focuses on developing and maintaining quality standards, collaborating with engineering and manufacturing, and applying robust validation and testing to ensure compliant products and processes. Strong analytical and problem-solving skills are essential.