Quality Management System (QMS) Coordinator

DDS LAB LLC•Tampa, FL

2d•Onsite

About The Position

The Quality Management System (QMS) Coordinator is responsible for the day-to-day administration, maintenance, and continuous improvement support of the organization’s QMS. This role partners with cross-functional departments to manage controlled documents, coordinate periodic reviews, administer training and employee acknowledgments, and provide administrative support to the Complaints Team as needed.

Requirements

High school diploma or equivalent required; associate or bachelor’s degree preferred.
2+ years of experience in a quality system, document control, training administration, regulated environment, or similar administrative/coordination role.
Working knowledge of document control principles (version control, approvals, effective dates, retention).
Experience supporting training assignment/tracking and maintaining training records.
Proficiency with common business software (e.g., Microsoft Office: Word, Excel, Outlook) and comfort learning new systems.
Strong attention to detail, organization, and follow-through; ability to manage multiple priorities and deadlines.
Clear written and verbal communication skills and the ability to collaborate across departments.

Nice To Haves

Familiarity with quality standards/regulations applicable to the organization (e.g., ISO 9001, ISO 13485, 21 CFR Part 820, GMP concepts), as relevant.
Experience supporting complaint handling workflows and/or quality records management.
Experience with audit preparation, CAPA documentation support, or quality metrics reporting.

Responsibilities

Administer the Quality Management System (QMS) platform, including user access support, basic configuration, and troubleshooting coordination with the system vendor as applicable.
Support management and process owners in developing, formatting, and updating QMS-related documents (e.g., procedures, work instructions, forms, templates, when applicable, related training assessments).
Ensure documents follow established document control requirements, including version control, approvals, effective dates, archival/retention, and distribution.
Facilitate the document control approval process, monitoring upcoming/past due approvals, sending reminders.
Build and maintain the QMS training module(s), partner with departments to establish training profiles, link-controlled documents to training profiles for documenting employee acknowledgment/receipt of training in the QMS system.
Provide guidance to stakeholders on training workflow, acknowledgment requirements, and best practices for effective learning documentation.
Maintain training records in accordance with internal requirements and applicable regulatory/standard expectations.
Facilitate controlled document periodic review process by assigning documents to the appropriate owner and monitoring upcoming/past-due reviews and sending “needs completion” reminders to document owners.
Prepare and distribute periodic metrics/reports (e.g., document approval status, document periodic review status, and training compliance status) to support management review and continuous improvement.
Support internal and external audits by retrieving controlled documents/records and providing objective evidence as requested.
Provide administrative support to the Complaints Team as needed (e.g., intake coordination, tracking/log maintenance, record completeness checks, document retrieval, meeting scheduling, and follow-up communications).
Assist with complaint file organization and readiness for review/audit, ensuring documentation is complete and filed in the appropriate QMS locations.