JT041 - MANUFACTURING ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA is seeking a production support engineer to strengthen our team. You will work on testing methods, procedures, and solving device/product yield problems, while coordinating with suppliers and implementing engineering changes.

The role involves IT system upgrades, validation activities, and maintaining controlled documentation across manufacturing equipment and processes, with emphasis on compliance to quality systems and regulatory

Qualifications

• Bachelor's degree in engineering.
• Minimum 2 years of relevant experience in manufacturing, engineering, validation, or related environments.
• Ability to support project schedules including overtime and weekend work when required.

Responsibilities

• Responsible for production support engineering with respect to testing methods, procedures, and problems; device/product and yield problems; analysis of product rejection; supplier related engineering changes and optimizing production relative to cost constraints.
• Supports manufacturing operations by assisting with IT system upgrades, computer system validation activities, and controlled documentation updates related to manufacturing equipment and processes.
• Assist with documentation updates and change control activities related to manufacturing systems and processes.
• Ensure compliance with internal quality systems, validation procedures, and regulatory standards.
• Collaborate with cross-functional teams including IT, Manufacturing, Engineering, and Quality to support project execution.

Skills

CSV

Manufacturing IT systems

Change management

Education

Bachelor's degree in engineering

Tools

Computer System Validation (CSV)

Manufacturing Equipment System Integration

Documentation/Change control systems

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:

• Responsible for production support engineering with respect to testing methods, procedures, and problems; device/product and yield problems; analysis of product rejection; supplier related engineering changes and optimizing production relative to cost constraints.
• Supports manufacturing operations by assisting with IT system upgrades, computer system validation activities, and controlled documentation updates related to manufacturing equipment and processes.
• Assist with documentation updates and change control activities related to manufacturing systems and processes.
• Ensure compliance with internal quality systems, validation procedures, and regulatory standards.
• Collaborate with cross-functional teams including IT, Manufacturing, Engineering, and Quality to support project execution.

Qualifications:

• Bachelor's degree in engineering
• Minimum 2 years of relevant experience in manufacturing, engineering, validation, or related environments.
• Ability to support project schedules including overtime and weekend work when required.
• Computer System Validation (CSV)
• Manufacturing Equipment System Integration
• IT Systems in Manufacturing Environments
• Validation Documentation and Change Management

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.