What are the responsibilities and job description for the Quality Specialist position at COMBE INCORPORATED.?
On-site in Rantoul, IL (not remote or hybrid)
Combe is a privately held, values-driven company with a long history of building trusted consumer brands. We offer the stability of an established organization with the agility to innovate and improve continuously. At Combe, employees are empowered to take ownership of their work, collaborate across functions, and make a meaningful impact. We value integrity, accountability, and respect—and we invest in our people through development opportunities, competitive benefits, and a supportive workplace culture.
Position Summary
The Quality Specialist supports daily manufacturing quality activities to ensure products meet regulatory and company requirements. This role maintains the electronic Quality Management System (Master Control), assists Production with quality issues, and provides documentation and process support during new equipment or production line installations. This is a hands-on role focused on Quality Systems management and on-the-floor quality support. There are no direct reports.
Key Responsibilities
Quality Systems & Documentation
- Maintain and administer MasterControl including SOP updates, training assignments, and document revisions.
- Support creation, revision, and organization of Quality documentation, including Device History Records (DHRs), forms, logs, and controlled documents.
- Assist with internal and external audit activities.
- Ensure compliance with Quality System Regulations (QSR), ISO requirements, and company policies.
Manufacturing Quality Support
- Work with Production to troubleshoot quality issues on the manufacturing floor.
- Support investigations for nonconformances, deviations, and customer complaints.
- Assist with CAPA documentation, follow-up, and closure.
- Participate in Material Review Board (MRB) activities.
- Maintain inspection processes and sampling plans as needed.
New Line & Equipment Support
- Provide quality input during new equipment or production line installations.
- Assist with documentation, quality checks, and readiness requirements during equipment qualification or implementation.
Data & Continuous Improvement
- Collect, organize, and report basic quality metrics.
- Identify trends and escalate issues when needed.
- Support continuous improvement efforts across manufacturing and quality teams.
Qualifications
- 3–5 years of manufacturing quality experience; medical device or FDA-regulated environment preferred.
- Working knowledge of Quality Systems and quality documentation.
- Experience supporting production teams and quality investigations.
- Familiarity with electronic QMS platforms (MasterControl preferred).
- Strong communication and collaboration skills.