What are the responsibilities and job description for the Quality Systems Coordinator position at Ortho Development Corporation?
- Location:** Onsite - Draper, UT
- Schedule:** Monday- Friday
- 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
- 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)
- 1--3 years of experience in Quality Assurance or Compliance support roles
- Experience maintaining QA logs, metrics, and records within a regulated industry
- 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
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