JT371 - SR QUALITY ENGINEER

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, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

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

Qualifications:

• Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field preferred.
• Experience in FDA/ISO-regulated manufacturing environments,including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
• Knowledge of validation and manufacturing processes,including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
• Proficiency in problem-solving, risk assessment, and data analysis tools,including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring.
• Experience with quality and businesssystems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma certification and automation/programming experience are preferred.
• Availability for 1st shift and 2shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.