Facilities & Quality Systems Engineer – CAPA & Change Controls

QRC Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico seeks a Facilities and Engineering Support Specialist to maintain the integrity and compliance of the manufacturing facility. You will support Quality Systems, including deviations, CAPAs, Change Controls, and documentation management.

Work with Quality, Facilities, and cross-functional teams to ensure timely execution, regulatory readiness, and a state-of-the-art pest control program.

Qualifications

• Education as stated: Doctorate with 2+ years of engineering experience, or Masters with 6 years, or Bachelor's with 8 years of related experience.
• Strong knowledge of Quality Systems, deviations, CAPA management, Change Controls, and controlled documentation.
• Experience supporting OEFM electronic forms or similar electronic quality/facilities management systems preferred.
• Understanding of pest control programs in a regulated manufacturing environment.
• Knowledge of FDA regulatory requirements and other authorities.
• Excellent organization, communication, and problem-solving skills.
• Detail-oriented with focus on quality, compliance, and timely execution.

Responsibilities

• Provide primary support for Quality Systems activities including deviations, CAPAs, Change Controls, and related quality documentation.
• Investigate and document deviations from procedures or specifications following SOPs.
• Collaborate with Quality team to initiate, implement, monitor, and close CAPAs in a timely manner.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
• Facilitate and manage documentation changes related to facilities and engineering processes.
• Support creation, review, routing, and tracking of OEFM electronic forms.
• Collaborate with cross-functional teams to resolve form-related questions or issues.
• Support the Pest Control program and coordinate with external vendors and internal teams.
• Assist Change Control by evaluating proposed changes and maintaining records for regulatory inspections.

Skills

Quality Systems

CAPA management

Change Controls

Documentation

Regulatory knowledge

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Tools

OEFM electronic forms

Electronic quality systems

Job description

QRC Group in Juncos, Puerto Rico seeks a Facilities and Engineering Support Specialist to maintain the integrity and compliance of the manufacturing facility. You will support Quality Systems, including deviations, CAPAs, Change Controls, and documentation management.

Work with Quality, Facilities, and cross-functional teams to ensure timely execution, regulatory readiness, and a state-of-the-art pest control program.