Intern, System Administrator, Quality Systems

Intern, System Administrator, Quality Systems

• Assist Quality Systems team members with the administration and support of the EtQ Reliance Quality Management System under direct supervision.
• Support basic system configuration activities and learn how system changes are implemented based on user and business requirements, including the subsequent validation of those changes.
• Assist with documenting system requirements, user needs, and supporting materials in accordance with established TIDI procedures and software development practices.
• Support software updates, patches, and system enhancements by helping with preparation, documentation, and testing activities.
• Assist in troubleshooting system issues by managing the EtQ System Helpdesk, gathering clarifying information on the request, documenting observations, and escalating items to appropriate team members and making updates including user profiles and pick lists.
• Support validation-related activities by assisting in the preparation, execution, and documentation of validation protocols / scripting and deliverables. Train SMEs on Script execution.
• Participate in system and software requirement reviews to gain understanding of system design, functionality, and regulatory considerations.
• Assist with maintaining system-related documentation, including procedures, work instructions, and training materials in a GMP / GDP compliant manner.
• Support the Quality Systems team with managing and organizing items within the internal EtQ support inbox (EtQ Helpdesk).
• Assist with user support activities, including helping prepare training materials and documentation for system users.
• Support integration or data exchange activities with other enterprise systems (e.g., ERP systems) by assisting with documentation and coordination efforts, including field mapping.
• Participate in project meetings, check-ins, and discussions to gain exposure to project management and cross-functional collaboration and reporting results / milestones against project timelines.
• Support internal and external audit preparation activities by assisting with document gathering and logistical support.
• Comply with applicable medical device regulatory requirements, good software development practices, GAMP5, company policies, and standard operating procedures, work instructions and standard work while performing assigned tasks.
• Perform additional Quality department support activities as assigned, consistent with internship learning objectives and departmental needs.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.

• Understands internal and external customers
• Assure a safe work environment
• Demonstrates teamwork and flexibility/adaptability
• Demonstrates honesty
• Keep our commitments
• Think systemically and ensure constancy of purpose
• Lead with humility and respect every individual
• Focus on process, embrace scientific thinking, flow and pull value, assure quality at the source and seek perfection

• Currently pursuing a bachelor's degree in information technology (IT) systems, Computer Science, Quality, Engineering, Business, or a related field; or recent graduate within one year of degree completion.
• Coursework or academic projects related to information technology, software development, IT system administration, Quality Management Systems, data management, or regulated environments is preferred.
• No prior professional Quality Systems or medical device industry experience required Training opportunities is available for the right candidate.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability and willingness to learn Quality Management System concepts and regulatory requirements (e.g., FDA QMSR, ISO 13485:2016, EU / UK MDR, MDSAP, etc.) through training and supervised oversight of work.
• Basic understanding or academic exposure to software system development and lifecycle management, creation and maintenance of databases, and /or enterprise applications preferred.
• Strong attention to detail with the ability to follow instructions, procedures, and documented processes.
• Effective written and verbal…