Quality Systems Coordinator

• Location:** Onsite - Draper, UT
• Schedule:** Monday- Friday

Your Responsibilities

• Maintain and update Quality System logs and databases (e.g., CAPA, Field Actions, QSMR trackers).
• Track task status and follow up with responsible personnel to ensure timely completion of quality actions.
• Prepare draft reports, summaries, and metrics for review by the Quality Systems Section Manager.
• Assist in compiling QSMR data, metrics, and presentations.
• Support documentation of Field Actions and CAPA records, ensuring required evidence and approvals are complete.
• Support implementation and maintenance of electronic Quality Management System (eQMS) tools, including MasterControl modules related to CAPA, Training, and QSMR documentation.
• Serve as a backup for the Training Coordinator, assisting with maintenance of training records, matrices, and completion tracking when needed.
• Assist with document updates, form revisions, and change control requests related to Quality System activities.
• Participate in internal audit preparation by providing objective evidence and record retrieval.
• Serve as a trained backup Internal Auditor when additional audit resources are required.
• Provide administrative support for meetings, schedules, and follow-ups within the Quality Systems area.
• Perform other job-related duties as assigned

Requirements

• Associates degree in Quality, Business Administration, or Technical field
• ISO 13485 Internal Auditor Training Preferred
• ISO 13485 / FDA 21 CFR Part 820 (QSR) Awareness
• CAPA System and Problem-Solving Tools
• Document Control and Electronic QMS Applications (Preferred)

Experience Specific To This Position

• 1--3 years of experience in Quality Assurance or Compliance support roles
• Experience maintaining QA logs, metrics, and records within a regulated industry

Other Skills

• Strong attention to detail and accuracy in data entry and documentation
• Excellent organization and follow-up skills
• Proficient in Microsoft Office and electronic QMS tools (e.g., MasterControl, Smartsheet, D365)
• Ability to communicate clearly and work collaboratively across departments
• Proficient in Microsoft Office and electronic QMS tools (e.g., MasterControl, Smartsheet, D365); able to learn and navigate new systems efficiently