Quality Engineering and Regulatory Affairs Intern

Fortifi • Wakeman, OH

1d

About The Position

The Quality Engineering and Regulatory Affairs Intern assists the QA/RA team with projects and daily tasks related to maintaining quality-system compliance for medical device manufacturing, including clean room operations. The intern also supports other functional departments or product staff while assisting the QA/RA Manager. This full-time position runs approximately from January 2027 to March 2027.

The intern supports regulatory activities, corporate quality, plant quality oversight, microbiology and sterilization, and document control. The role also participates in equipment and clean room installation, operational, and performance qualifications (IQ, OQ, and PQ), and prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends.

Requirements

• At least a high school education and completion of at least one year of college.
• Currently pursuing a bachelor's or master's degree in engineering, quality, regulatory, life sciences, or a similar degree program.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office.
• Behave ethically and ensure conduct is consistent with ethical standards and organizational values.
• Communicate clearly, thoroughly, and in a timely manner using appropriate communication tools and techniques.
• Develop new and unique ways to improve functional efficiency and performance.
• Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that improve process effectiveness.
• Set priorities, develop work schedules, monitor progress toward goals, and track details and information.
• Set goals, create and implement action plans, and evaluate processes and results.
• Assess problem situations, identify causes, gather and process relevant information, generate possible solutions, and make recommendations to the manager.
• Demonstrate the stated values of courage, creativity, and authenticity.

Responsibilities

• Assist the QA/RA team with regulatory activities, corporate quality, plant quality oversight, microbiology and sterilization, and document control.
• Participate in developing and executing installation, operational, and performance qualifications (IQ, OQ, and PQ) for equipment, including the clean room.
• Prepare quality documentation, including ERTs, CRTs, and Management Review materials.
• Prepare reports by collecting, analyzing, and summarizing information and trends related to failed processes, stability studies, recalls, corrective actions, and re-validations.
• Support other functional departments or product staff while assisting the QA/RA Manager.

What This Job Offers

• Job Type: Full-time
• Career Level: Intern
• Education Level: High school or GED