Quality Intern I

Description

We are seeking a detail-oriented Quality Systems Intern I to support our Quality Systems Administrator and Quality Documentation Specialist. In this role, you’ll assist with key administrative functions that keep our Quality Management System running effectively — including documentation control, corrective and preventive actions, complaint handling, nonconforming product processes, and internal audits.

This is an excellent opportunity for a student interested in quality systems, regulatory compliance, or medical device manufacturing.

What You’ll Do

• Assist in maintaining quality system documents and records in alignment with FDA Quality Management System Regulations (QMSR).
• Support document control and change management by reviewing change packets for completeness and accuracy.
• Assist with internal audits according to the internal audit schedule.
• Review and perform initial actions for medical device complaints.
• Participate in periodic complaint review meetings.
• Monitor, track, investigate, and expedite Corrective Actions (CAs) and Preventive Actions (PAs).
• Review documents for consistency, formatting, and grammatical accuracy.
• Facilitate the flow of quality documentation through review and approval phases.
• Maintain administrative logs with accuracy and completeness.
• Assist with preparation of documentation and presentations for Management Review.
• Support implementation of procedures and work instructions related to quality systems.
• Assist in other Quality Department tasks as needed.

Requirements

What You Bring

Education & Experience

• Currently pursuing a bachelor’s degree; minimum of two years of college coursework completed.
• Interest in working in a GMP-regulated environment (preferred).
• Experience with engineering or technical documentation (a plus).

Skills & Competencies

• Excellent organizational skills and strong attention to detail.
• Working knowledge of Adobe Acrobat and Microsoft Office applications.
• Strong interpersonal and communication skills.

Additional Necessities

This role is primarily office-based with frequent sitting, talking, typing, and handling documents. Occasional standing, walking, bending, and light lifting (up to 10 lbs). Good vision and hearing are required for daily tasks.

Why Join Us?

• Opportunity to gain hands-on experience in a regulated quality environment.
• Mentorship from experienced quality professionals.
• Exposure to medical device quality systems and compliance processes.