Quality Management System Coordinator

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.

Key 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Core Competencies Document control & data integrity: Maintains accurate records and controlled content with disciplined attention to detail.

Collaboration: Works effectively with process owners, management, and cross-functional teams to meet QMS needs.

Customer service mindset: Responds promptly and professionally to user questions and support requests.

Process orientation: Follows defined workflows and identifies opportunities to streamline and standardize.

Confidentiality: Handles quality records and complaint-related information appropriately.

Must be able to manage competing priorities in a deadline-driven environment.