Quality Systems Intern

• Job Category: Engineering , Manufacturing , Quality

The Quality Systems Intern supports Medbio’s Medical Device Quality Management System (QMS) and works directly with the Quality Manager on strategic quality initiatives. Primary responsibilities include supporting a comprehensive QMS assessment and remediation effort to ensure compliance with ISO 13485 and FDA Quality Management System requirements and executing validation activities for the DELMIAWorks/IQMS ERP system. This internship provides hands‑on experience in medical device quality systems, regulatory compliance, document control, computerized system validation, and audit readiness activities.

• Support a comprehensive Quality Management System assessment and remediation project.
• Review, draft, revise, and update quality procedures, work instructions, forms, and records.
• Identify documentation gaps and implement quality system improvements under supervision.
• Support document control, change management, and revision control activities.
• Develop and assist with training related to significant quality system changes.
• Execute approved DELMIAWorks/IQMS ERP validation protocols and document results.
• Maintain validation records and supporting objective evidence.
• Organize and analyze quality-related data and prepare reports as assigned.
• Support audit and inspection readiness activities.
• Maintain confidentiality of quality, regulatory, and validation records.
• Collaborate with cross‑functional departments to support quality initiatives.
• Perform other duties and projects as assigned by the Quality Manager.

Reports directly to the Quality Manager and may interact with Manufacturing, Operations, Engineering, Supply Chain, and IT personnel.

• Required:
  • Pursuing a Bachelor’s or Master’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related STEM discipline.
  • Strong attention to detail and commitment to accuracy.
  • Self‑motivated with the ability to work independently.
  • Strong written communication skills.
  • Strong organizational, analytical, and problem‑solving abilities.
  • Proficiency with Microsoft Office applications
  • Comfortable with the use of AI.
• Preferred:
  • Junior, Senior, or Graduate‑level standing
  • Interest in medical devices, quality systems, regulatory compliance, validation, or quality engineering.
  • Familiarity with ISO 13485, FDA regulations, or regulated manufacturing environments.

• Primarily office‑based work involving computer use, document review, and data analysis.
• Ability to sit, stand, and work at a computer for extended periods.
• Ability to occasionally lift up to 20 pounds.
• Ability to occasionally access manufacturing and warehouse areas.