Senior Quality Systems Engineer - CAPA & Change Controls

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a Sr Specialist Tech Engineer to support Quality Systems, deviations, CAPAs, and Change Controls within our facilities and manufacturing operations.

This role emphasizes documentation changes, OEFM electronic forms, pest control program management, and regulatory compliance with FDA requirements, ensuring timely, accurate records and strong cross‑functional collaboration.

Qualifications

• Doctorate degree with 2 years engineering experience.
• Master's degree with 6 years engineering experience.
• Bachelor's degree with 8 years directly related experience.

Responsibilities

• Provide primary support for Quality Systems activities, including deviations and CAPAs.
• Manage documentation changes for facilities and engineering processes.
• Support creation, review, routing, and tracking of OEFM electronic forms.
• Support transformation and operation of the Pest Control program.
• Assist Change Control processes and maintain related records.

Skills

Quality Systems

CAPA management

Change Controls

Documentation

OEFM electronic forms

Pest control program knowledge

Regulatory compliance

Communication skills

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a Sr Specialist Tech Engineer to support Quality Systems, deviations, CAPAs, and Change Controls within our facilities and manufacturing operations.

This role emphasizes documentation changes, OEFM electronic forms, pest control program management, and regulatory compliance with FDA requirements, ensuring timely, accurate records and strong cross‑functional collaboration.