Quality Systems Coordinator: Document Control & Compliance

KI MOBILITY; Stevens Point (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

KI Mobility in Stevens Point, WI, is seeking a Quality Systems Coordinator to support the administration and maintenance of the QMS across QA and Regulatory affairs, including document control, training records, audits, and data reporting.

The role ensures compliance with FDA, ISO 13485, and applicable standards while enabling QA and Regulatory staff to focus on risk management, investigations, and continuous improvement.

Qualifications

• 1–3 years of administrative, document control, records management, data entry, or manufacturing support experience.
• Intermediate proficiency with Microsoft Office (Word, Excel, Outlook, Teams).
• Strong attention to detail and organizational skills.
• Experience in a manufacturing or regulated environment preferred.

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.
• Maintain a safe, neat and orderly work environment.
• Ensure and follow safety requirements and standards.
• Adhere to Company’s Quality System requirements.
• Performs all duties in a manner that follows, demonstrates, and promotes Company’s values.
• Report to work as scheduled, on time, and able to work the entire work schedule.
• Perform additional duties as assigned.

Skills

Attention to detail

Organizational skills

Multitasking

Communication skills

Teamwork

Education

Equivalent combination of education and experience

Tools

Microsoft Office

Job description

KI Mobility in Stevens Point, WI, is seeking a Quality Systems Coordinator to support the administration and maintenance of the QMS across QA and Regulatory affairs, including document control, training records, audits, and data reporting.

The role ensures compliance with FDA, ISO 13485, and applicable standards while enabling QA and Regulatory staff to focus on risk management, investigations, and continuous improvement.