Quality Engineering and Regulatory Affairs Intern

About the Role

Internship opportunity at Exsurco Medical focused on Quality Engineering and Regulatory Affairs.

Key Responsibilities

• Assist the QA RA Team with:
• Regulatory Activities
• Corporate Quality
• Oversight of Plant Quality
• Microbiology/Sterilization
• Document Control
• Participate in the development and execution of installation, operational and performance qualifications of equipment (IQ, OQ and PQ), including the clean room.
• Prepare quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends, including:
• Failed processes
• Stability studies
• Recalls
• Corrective actions
• Re-validations

Requirements & Tech Stack

• Proficiency with Microsoft Office

Qualifications

• Education:
• Minimum of high school education & completed one year of college minimum.
• Actively pursuing a bachelor’s or master’s degree in engineering, quality, regulatory, life sciences, or a similar degree program.
• Skills:
• Excellent communication skills (written and verbal).
• Personal Characteristics:
• Behave Ethically: Understand and exhibit ethical behavior, ensuring consistency with organizational values.
• Communicate Effectively: Speak, listen, and write clearly and thoroughly using effective tools and techniques.
• Creativity/Innovation: Develop new and unique ways to improve function efficiency and performance.
• Foster Teamwork: Cooperate effectively with others to set goals, resolve problems, and make decisions.
• Organize: Set priorities, develop work schedules, monitor progress, and track details/data/information/activities.
• Plan: Set goals, create and implement action plans, and evaluate processes and results.
• Solve Problems: Assess situations, identify causes, gather information, generate solutions, and make recommendations.