Quality Management System Specialist (Direct Hire)
Gays Mills, WI
Job Requisition: 7470
Description for QMS Specialist:
The QMS Specialist is responsible for maintaining and updating quality management system documentation in alignment with ISO 9001:2015 standards and company procedures. This includes managing procedures, work instructions, forms, and records, as well as supporting internal and external audits by organizing planning, execution, reporting, and follow-up activities. The role involves monitoring nonconformities and corrective actions, supporting continuous improvement efforts through data analysis and process tracking, and overseeing document control to ensure accurate versioning and accessibility. The QMS Specialist also assists in quality-related administrative tasks, facilitates employee training on QMS procedures, and collaborates across departments to promote alignment with quality standards.
Responsibilities for QMS Specialist:
- Maintain and revise QMS documents such as procedures, work instructions, forms, and records to meet ISO 9001:2015 and internal standards
- Coordinate and take part in internal audits, including scheduling, conducting, reporting, and tracking follow-up actions
- Support external audits conducted by registrars, customers, or regulatory bodies
- Track and manage nonconformances and CAPAs, ensuring timely closure, documentation, and review for effectiveness
- Assist with continuous improvement efforts by gathering and analyzing quality data and monitoring process enhancements
- Oversee document control to ensure accurate versioning and proper access to current documentation
- Verify adherence to customer and regulatory requirements related to quality records and documentation
- Support quality-related activities such as management reviews, risk evaluations, and KPI monitoring
- Help develop and deliver training on QMS processes, document systems, and general quality practices
- Work closely with other departments to align practices with quality standards and drive a culture of compliance
- Ensure QMS records are maintained accurately and kept up to date
- Follow through on audits and CAPA activities within required timelines
- Contribute to strong audit performance for both internal and third-party assessments
- Encourage QMS understanding through training participation and employee engagement
- Stay current on industry trends by attending relevant workshops, reviewing literature, and building professional networks
- Take on additional tasks or projects as assigned to support broader team goals
Requirements for QMS Specialist:
- Internal Auditor Certification for ISO 9001 (or willingness to obtain)
- 2+ years of experience in quality systems or regulatory compliance within a manufacturing or technical environment
- Working knowledge of ISO 9001:2015 and general quality management principles
- Experience with document control, CAPA systems, and audit processes
- Proficient in Microsoft Office (Excel, Word, PowerPoint) and quality management software
- Experience with root cause analysis tools (5 Whys, Fishbone, Pareto) and continuous improvement techniques (Lean, Six Sigma)
Nice to Have:
- Bachelor’s degree (Engineering, Business, or related technical)
- Experience with QMS software
- Knowledge of ISO 14001 and 45001
- Electronics knowledge
- HVAC Knowledge
