Job Overview

Records Control Support works within the QMS team as the responsible party for providing administrative and coordination support to the Quality Systems function. This position maintains records and ensures compliance with QMSR and ISO 13485 standards. They process requests for record maintenance and retrieval and supports quality management activities across analytics and audit disciplines, gaining foundational experience in quality systems, reporting, and compliance. Develops knowledge of quality management principles, industry standards, and quality tools while contributing to data-driven improvement and audit readiness within manufacturing and operational environments.

Job Requirements

•Provides administrative and coordination support for day-to-day Quality Systems activities
•Support record control processes, including the management, organization, and maintenance of Quality Systems documentation within paper based and electronic systems
•Gains hands-on experience with quality tools and techniques while learning industry best practices and standards.
•Retrieves controlled records from multiple production and engineering and quality departments, as well as scan, organize, file and send externally for archival while ensuring compliance with record retention requirements.
•Provide administrative assistance with controlled logs for Risk Assessments, Validations, etc.
•Assist with audit support activities for internal and external audits, including preparation of documentation, on site administrative support, follow-up and liaison with relevant personnel.
•Distribute new copies and retrieve previous versions of controlled documents to the production floor and other points of use areas in a timely manner
•Maintain document and records management systems to ensure efficient storage, retrieval, retention, and traceability.
•Compile and distribute Quality Systems reports and metrics

• Must be able to lift and carry a maximum weight of 20-30 lbs safely & dependably
• Frequently required to extend arms and hands between knees & shoulders; frequent holding and grasping with hands.
• Frequent standing and walking are required in this job.

What your background should look like

•High school diploma required
•Basic awareness of Quality Management Systems and GMP understanding preferred. Familiarity with ISO 13485 standards preferred
•6 months to (1) year of experience in the medical device, or other regulated industry preferred
•Hands on skills in Office software required, e.g., Word, Excel.
•Proficient computer and typing skills
•Excellent attention to detail, strong organization required
•Must be flexible and able to manage changing priorities and tight timelines
•Excellent problem-solving techniques
•Excellent communications skills
•Ability to work with many different levels of the organization for successful coordination and implementation of document and specification changes

Competencies