Quality Systems Coordinator

Job Description

Position Summary:

The Quality Systems Coordinator serves as the organization's primary administrator of controlled Quality Management System documentation and records. This position is responsible for maintaining documented information, supporting training and competency records, assisting with internal audits, and supporting certification and surveillance audits. The role works cross-functionally with all departments to ensure compliance with ISO 9001 requirements and continual improvement of the Quality Management System.

Key Areas of Responsibilities:

• Maintains the organization's document control processes in accordance with Quality Management System requirements and ISO 9001.
• Administers policies, procedures, work instructions, forms, records, process maps, and other QMS documentation.
• Coordinates document creation, review, revision, approval, release, distribution, retention, and archival.
• Ensures only current approved revisions are available at points of use.
• Maintains document revision histories and change records.
• Collaborates with process owners and department leaders to develop and improve documentation.
• Performs periodic reviews of controlled documents for accuracy and compliance.
• Maintains electronic document management systems and document repositories.
• Maintains quality records in accordance with retention requirements.
• Assists with administration of training and competency records.
• Supports implementation and continual improvement of the QMS.
• Assists in preparation for certification audits, surveillance audits, and internal audits.
• Participates in internal quality audits and process audits as assigned.
• Documents audit findings and assists with tracking corrective action records.
• Generates reports and metrics related to document control and QMS effectiveness.
• Maintains confidentiality of proprietary and controlled information.
• Adheres to all company safety policies and procedures.

This list of responsibilities is not exhaustive. Other duties may be required to be undertaken which fall within the scope and general level of responsibility attached to the role.

Functional Knowledge:
Applies working knowledge of Quality Management Systems, document control principles, and organizational processes to support compliance and continual improvement.

Business Expertise:
Understands how documented information supports organizational operations, compliance, training & competency, and audit readiness across multiple departments.

Leadership:
Has no direct supervisory responsibilities but serves as a resource regarding document control requirements and Quality Management System processes.

Problem Solving:
Identifies documentation discrepancies, process gaps, and conformance concerns and works with process owners and stakeholders to implement effective solutions.

Key Performance Indicators:

• Develops the skills obtained through prior experience and/or formal training to perform key responsibilitiesasprovided by the Quality Manager.
• Ability to follow standard operating procedures and apply basic analytical skills to perform activities.
• Workswith others in a manner that promotes teamwork, learning and development of self and of others.
• Completes work assignments on a timely basis.

Job Knowledge, Skills, and

Experience:

• High School Diploma or equivalent required.
• Associate’sor Bachelor's Degree is preferred.
• Minimum two years of experience working within an ISO 9001 Quality Management System environment required.
• Experience with document control, quality systems administration, records management, or quality assurance activities required.
• Experience in a manufacturing environment preferred.
• Internal Auditor training or experience preferred.
  
  Working knowledge of ISO 9001 requirements and QMS principles.
• Strong technical writing, proofreading, and document editing skills.
• Proficiency with Microsoft Office applications including Word, Excel, Outlook, and PowerPoint.
• Strong organizational, communication, and time management skills.
• Ability to support internal audits, certification audits, and continual improvement initiatives.