Quality Systems Coordinator

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Full Time Stevens Point, WI, US

4 days ago Requisition

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. The position helps ensure quality system activities remain organized, timely, and compliant with FDA, ISO 13485, and other applicable regulatory requirements while enabling Quality and Regulatory personnel to focus on compliance, risk management, investigations, and continuous improvement activities.

• 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.

• 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.
• Ability to maintain confidential and sensitive information appropriately.
• Ability to work effectively both independently and within a team environment.
• Basic analytical and problem-solving skills.
• Ability to compile, organize, and report quality system data.
• Ability to follow procedures and maintain accurate records.
• Ability to adapt to changing business needs and priorities.
• Demonstrated professionalism, accountability, and reliability.
• Ability to observe and identify details.
• Ability to work extended hours as scheduled, including weekends.

• Frequent sitting, wrist manipulation, walking, and standing.
• Frequent sedentary work with lifting and carrying up to 10 pounds.
• Occasional medium work with lifting and carrying up to 40 pounds.
• Manual dexterity to type and operate office equipment occasionally.
• Must be able to…