Quality Engineer II - GMP/ISO Compliance & Process Improvement

Quality Consulting Group, LLC; Humacao (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a quality engineer to join our team supporting pharmaceutical, biotech, medical devices, and manufacturing operations in Puerto Rico and the mainland U.S.

You will develop and maintain quality standards, lead inspections and validation activities (IQ/OQ/PQ), and collaborate with engineering to drive process improvements in a GMP environment. Strong data analysis and cross-functional communication are essential.

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field preferred.
• 2+ years of related experience in FDA/ISO-regulated manufacturing environments.
• Experience with validation (IQ/OQ/PQ), CAPA, nonconformance, change control and risk management.

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 for inspecting, testing and evaluating products and equipment.
• Designs or specifies inspection/testing mechanisms; conducts QA tests; and performs statistical analysis to assess failures.
• Ensures corrective actions meet reliability standards and documentation is compliant.
• May specialize in design, incoming material, production control, product evaluation and reliability.
• Collaborate closely with cross-functional teams to develop innovative solutions and improve manufacturing processes.

Skills

2+ years experience

Problem-solving

Communication skills

Lean Six Sigma

FMEA

5 Whys

Fishbone

DOE

SPC

Process monitoring

Minitab

JMP

Excel

Power BI

SAP

IQ/OQ/PQ validation

Education

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

Tools

IQ/OQ/PQ validation

Automation knowledge

Job description

QUALITY CONSULTING GROUP, LLC is seeking a quality engineer to join our team supporting pharmaceutical, biotech, medical devices, and manufacturing operations in Puerto Rico and the mainland U.S.

You will develop and maintain quality standards, lead inspections and validation activities (IQ/OQ/PQ), and collaborate with engineering to drive process improvements in a GMP environment. Strong data analysis and cross-functional communication are essential.