Quality Systems Coordinator

About the role

The Quality Systems Coordinator is responsible for supporting the administration and maintenance of the Quality Management System (QMS) across Quality Assurance and Regulatory Affairs functions. This role coordinates document control activities, training records, complaint documentation, audit support, quality system records, and quality data reporting.

Responsibilities

• Maintain controlled quality documents, records, forms, SOPs, work instructions, and templates within document management systems, ensuring accuracy, compliance, and accessibility.
• Coordinate document revisions, formatting, routing, review, approval, distribution, and document control activities.
• Review documents for formatting, completeness, consistency, and compliance with document control requirements.
• Support internal and external audits by scheduling activities, collecting records, preparing documentation, and tracking audit findings, and following up on corrective actions and quality system commitments.
• Maintain employee training records and matrices while supporting onboarding and training documentation activities.
• Enter, organize, review, and maintain quality system records within electronic databases and enterprise software systems.
• Maintain Quality Management System records, logs, and performance metrics, as well as, organized electronic and physical filing systems.
• Support complaint handling activities through data entry, file maintenance, documentation control, and record organization.
• Assist quality personnel with investigations by gathering information and preparing supporting documentation.
• Compile quality metrics, reports, and trending data for management review and continuous improvement activities.
• Support supplier quality and compliance activities as assigned.
• Perform routine data analysis and trending using spreadsheets and reporting tools.
• Participate in continuous improvement projects and quality system improvement initiatives.
• Ensure adherence to ISO 13485, FDA Quality System Regulation (QMSR), and other applicable regulatory requirements.

Requirements

• High school diploma or equivalent required; Associate degree preferred.
• Relevant quality, business, or administrative coursework beneficial.
• 1-3 years of administrative, document control, records management, data entry, or manufacturing support experience.
• Intermediate proficiency with Microsoft Office applications including Word, Excel, Outlook, and Teams.
• Strong attention to detail and organizational skills.

Skills

• Strong attention to detail and organizational skills.
• Ability to manage multiple tasks, priorities, and deadlines.
• Effective written and verbal communication skills.
• Proficiency using Microsoft Office applications, including Word, Excel, Outlook, and Teams.
• Ability to learn and utilize document control and quality management software systems.
• Basic analytical and problem-solving skills.
• Ability to compile, organize, and report quality system data.
• Ability to follow procedures and maintain accurate records.

Qualifications

Preferred qualifications include experience working in a manufacturing environment, experience with document control systems, training records, or quality records, and experience in a regulated industry (medical device, aerospace, automotive, pharmaceutical, etc.).

Working Environment

Standard working conditions include a temperature-controlled office and manufacturing environment. This position does not provide immigration sponsorship and is subject to a background check.