Job Description
Job Overview:
Job Summary
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.
Essential Functions
Job 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.
Knowledge, Skills, and Ability
- 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.
- Continuous improvement mindset.
- Demonstrated professionalism, accountability, and reliability.
- Ability to observe and identify details.
- Ability to work extended hours as scheduled, including weekends.
Physical Demands
- 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 complete all physical requirements to perform essential functions.
Qualifications
Education
- High school diploma or equivalent required; Associate degree preferred.
- Relevant quality, business, or administrative coursework beneficial.
- Equivalent combination of education and experience may be considered.
Experience
- Required:
- 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.
- Preferred:
- Experience working in a manufacturing environment.
- Experience with document control systems, training records, or quality records.
- 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 now or in the future provide immigration sponsorship.
This position is subject to a background check. A prior conviction or pending charge will not automatically disqualify you from consideration. In accordance with the Fair Credit Reporting Act and Wisconsin Fair Employment Act, criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodation.
Ki Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
