JT370 - QUALITY ENGINEER II

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, 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.
• Collaborate closely with cross-functional teams to develop innovative solutions and improve manufacturing processes.

Qualifications:

• Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field preferred.
• 2+ years of related experience
• 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

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.