What are the responsibilities and job description for the Quality Systems Coordinator position at Ortho Development Corporation?
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
Salary.com Estimation for Quality Systems Coordinator in Draper, UT
$83,448 to $103,960
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