Quality Control Specialist

Job Title: Document Control Specialist

Department: Quality

Reports to: Quality Manager

Location: On-Site-Menomonee Falls, WI

Shift: Mon-Fri 8-4:30

Position Summary

The Document Control Associate supports the creation, revision, issuance, and maintenance of controlled documents within an ISO 13485‑certified Quality Management System. This role ensures that all procedures, work instructions, forms, and records are properly controlled, current, and compliant with regulatory and internal requirements. The associate works closely with Quality, Operations, Engineering, and Regulatory teams to maintain document integrity, manage the QMS system, and support audit readiness.

Key Responsibilities

• Manage the full lifecycle of controlled documents, including creation, formatting, routing, approval, release, and archival.
• Maintain and administer the electronic QMS/document control system, ensuring accurate version control, user access, workflow routing, and system integrity.
• Review documents for completeness, clarity, formatting consistency, and compliance with ISO 13485 and internal QMS standards.
• Coordinate document change requests (DCRs), ensuring timely routing and communication with stakeholders.
• Support internal and external audits by providing controlled documents, records, and revision history.
• Ensure obsolete documents are removed from circulation and properly archived.
• Assist with training distribution and acknowledgment tracking for newly released or revised documents.
• Monitor and report document control and QMS system metrics and support continuous improvement initiatives.
• Maintain confidentiality and data integrity across all controlled documentation.

Qualifications

• 2+ years Education: Bachelor’s degree preferred (Quality, Life Sciences, Engineering, or related field) ; equivalent experience considered
• Experience Required: Minimum 2 years of experience in document control, quality assurance, or regulated manufacturing environment.
• Experience working within an ISO 13485, FDA 21 CFR Part 820, or similar regulated quality system preferred.
• Strong attention to detail, organization, and accuracy.
• Proficiency with document management systems or eQMS platforms.
• Ability to communicate clearly and professionally across departments.
• Familiarity with controlled document formatting, revision control, and change management processes.
• Ability to manage multiple priorities in a fast‑paced environment.