Document Control & QMS Specialist

Position Overview

Responsible for maintaining and controlling quality system documentation to ensure compliance with company procedures, customer requirements, and applicable quality standards. This role serves as the primary administrator of the Quality Management System (QMS), supporting document control, internal audits, audit readiness, training records, change management, and continuous improvement initiatives.

Key Responsibilities

Document Control & QMS Administration

· Maintain and control quality system documentation, including procedures, work instructions, forms, records, and quality manuals.

· Manage document revisions, approvals, distribution, archival, and retention activities.

· Coordinate document change requests and ensure only current, approved documents are available for use.

· Maintain training records, audit documentation, and controlled quality records.

· Support administration and continuous improvement of the Quality Management System (QMS).

Quality System Support

· Lead internal audits to evaluate compliance with QMS requirements, documented procedures, customer requirements, and applicable standards.

· Support internal and external audits through document preparation, organization, and follow-up activities.

· Partner with process owners to identify nonconformities, implement corrective actions, and drive continuous improvement initiatives.

· Monitor documentation compliance and assist with quality reporting and trend analysis.

Cross-Functional Collaboration

· Partner with Quality, Process Engineering, Production, Planning, and Operations to ensure documentation accurately reflects approved manufacturing practices.

· Lead the document lifecycle process for SOPs, work instructions, forms, templates, and quality records, including creation, review, approval routing, implementation, revision control, and periodic review.

· Provide guidance on document control procedures and quality system requirements.

Continuous Improvement

· Identify opportunities to improve document control processes and accessibility of information.

· Support quality system enhancements, standardization initiatives, and SAP readiness activities.

Required Qualifications

· Associate's degree or equivalent experience preferred.

· 2-5 years of document control, quality systems, compliance, or quality administration experience within a manufacturing environment.

· Experience working within an ISO-certified Quality Management System and Good Documentation Practices standards

· Proficiency with Microsoft Office applications, SharePoint, and document management systems.

· Strong organizational skills and attention to detail.

· Experience supporting ISO 9001, ERP, QMS, or electronic document management systems strongly preferred.