Quality Systems Coordinator
On-siteStevens Point, Wisconsin, United States
Job Summary
Maintain controlled quality documents, records, forms, SOPs, and templates within document management systems while coordinating revisions, formatting, routing, and distribution. Support internal and external audits by scheduling activities, collecting records, preparing documentation, and tracking findings and corrective actions. Enter, organize, and maintain quality system records, logs, and performance metrics in electronic databases and enterprise software. Assist with complaint handling through data entry, file maintenance, and documentation control, and gather information to support quality investigations. Compile quality metrics, reports, and trending data for management review and continuous improvement initiatives. Work the entire scheduled workweek, including weekends, in a temperature-controlled office or manufacturing environment. This role ensures QMS activities remain compliant with FDA, ISO 13485, and other regulatory requirements while enabling quality personnel to focus on compliance and risk management.
Required Qualifications
- High school diploma or equivalent
- Associate degree
- 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
- Ability to work extended hours as scheduled, including weekends
- Ability to work the entire work schedule
- Report to work as scheduled, on time
- 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 follow procedures and maintain accurate records
- 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 manage multiple tasks, priorities, and deadlines
- Effective written and verbal communication skills
- Must be able to complete all physical requirements to perform essential functions
- 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
- This position is subject to a background check
- A prior conviction or pending charge will not automatically disqualify you from consideration
- Criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position
Desired Qualifications
- Relevant quality, business, or administrative coursework
- Equivalent combination of education and experience
- 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.)
- Associate degree preferred
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