What are the responsibilities and job description for the Quality Systems Intern position at Medbio, LLC?
Summary of Function:
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.
Major Duties and Responsibilities:
Reports directly to the Quality Manager and may interact with Manufacturing, Operations, Engineering, Supply Chain, and IT personnel.
Experience and/or Educational Requirements:
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.
Major Duties and Responsibilities:
- 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.
Experience and/or Educational Requirements:
- 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.