Quality Engineer II: GMP/ISO & Process Improvement

qualityconsultinggroup; Humacao (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a QA/Quality Engineer to join its team in Puerto Rico/USA. The role focuses on developing and maintaining quality standards across materials and processes, collaborating with engineering and manufacturing to ensure compliance, and driving process improvements in a world-class manufacturing setting.

Qualifications include a Bachelor’s or Master’s in a related field, 2+ years of experience, and familiarity with GMP/ISO environments, validation, and quality

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field.
• 2+ years of related experience in quality/manufacturing.
• Experience in FDA/ISO-regulated manufacturing environments with GMP, ISO 13485, CAPA, nonconformance, change control, document control and risk management.
• Knowledge of validation (IQ/OQ/PQ), risk-based validation and manufacturing controls.
• Proficiency in problem-solving, risk assessment and data analysis tools (FMEA, 5 Whys, Fishbone, SPC, DOE, trend analysis).
• Experience with quality systems (Minitab, JMP, Excel, Power BI, SAP) and Lean Six Sigma certification preferred.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into finished or semi-finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Designs inspection/test mechanisms and conducts QA tests; analyzes data to address nonconforming materials.
• Ensures corrective measures meet reliability standards and documentation is compliant.
• Specializes in areas like design, incoming material, production control, reliability or R&D as applicable.
• Collaborate with cross-functional teams to develop innovative solutions and improve manufacturing processes.

Skills

2+ years experience

Problem solving

Data analysis

Communication

Education

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

Tools

Minitab

JMP

Excel

Power BI

SAP

Job description

Quality Consulting Group, LLC is seeking a QA/Quality Engineer to join its team in Puerto Rico/USA. The role focuses on developing and maintaining quality standards across materials and processes, collaborating with engineering and manufacturing to ensure compliance, and driving process improvements in a world-class manufacturing setting.

Qualifications include a Bachelor’s or Master’s in a related field, 2+ years of experience, and familiarity with GMP/ISO environments, validation, and quality