What are the responsibilities and job description for the Quality Systems Coordinator position at Ortho Development Corporation?
Quality Systems Coordinator
At Ortho Development, we help people do what they love by restoring mobility through innovative orthopedic hip and knee solutions. From our headquarters in Draper, Utah, we’re proud to provide meaningful work with a strong, collaborative culture where every team member can make a difference.
Here, you’ll find teammates who care, leadership that listens, and opportunities to learn, grow, and succeed. We offer competitive benefits, a workplace environment designed to help you thrive and promote work-life balance.
Here, you’ll find teammates who care, leadership that listens, and opportunities to learn, grow, and succeed. We offer competitive benefits, a workplace environment designed to help you thrive and promote work-life balance.
The Quality Systems Coordinator provides administrative and technical support for Quality System processes, including CAPA, Field Actions, and QSMR documentation. Maintains logs, records, and quality data; follows up on open items; and ensures documentation accuracy, traceability, and timely completion under the direction of the Quality Systems Section Manager. Acts as a backup for the Training Coordinator as needed to maintain training record integrity and support training documentation tasks. This full-time onsite position is available to start immediately and is a great opportunity in the exciting medical device industry.
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
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discounts
- Flexible spending account
- Health insurance
- Life insurance
- Paid Holidays
- Paid time off
- Parental leave
- Tuition reimbursement
- Vision insurance
- Wellness incentives
- UTA Transit Pass
