Quality Systems Documentation Specialist (QMS/PLM)

Comrise; Cary (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Comrise is seeking a Quality Systems Documentation Specialist to support a PLM implementation by updating and aligning QMS documentation with new workflows and system functionality.

The role focuses on rewriting and organizing documents, ensuring regulatory compliance, and collaborating with SMEs to validate accuracy while contributing to training materials and UAT activities.

Qualifications

• Bachelor's degree in Science, Engineering, Business, or related field.
• Experience maintaining or updating Quality Management System (QMS) documentation.
• Experience in regulated environments such as medical devices, pharmaceuticals, biotechnology, or FDA-regulated settings preferred.
• Familiarity with Product Lifecycle Management (PLM) systems.
• Strong technical writing, editing, and documentation skills.
• Experience supporting User Acceptance Testing (UAT) or developing test scripts is preferred.

Responsibilities

• Review and update QMS documentation including SOPs, work instructions, forms, templates, and procedures impacted by the PLM system.
• Rewrite and reorganize documentation to align with updated workflows, system functionality, and quality requirements.
• Ensure documentation complies with regulatory, quality, and internal standards.
• Collaborate with process owners, SMEs, and cross-functional teams to validate documentation accuracy and consistency.
• Support document change control activities to ensure documentation is approved and released prior to system go-live.
• Partner with the PLM implementation team to understand new system functionality and translate technical processes into clear documentation.
• Assist with User Acceptance Testing (UAT), including developing test scripts, documenting results, tracking defects, and resolving issues.
• Create and update training materials such as job aids, quick reference guides, SOP walkthroughs, and presentations.
• Support onboarding and training initiatives by gathering feedback and providing clarification on new processes.

Skills

Technical writing

Editing

Documentation

Regulated environments

UAT/test scripts

Cross-functional collaboration

Education

Bachelor's degree in Science, Engineering, Business, or related field

Tools

PLM systems

Job description

Schedule: Monday–Friday | 8:30 AM–5:00 PM CST

Position Overview

We are seeking a Quality Systems Documentation Specialist to support the implementation of a new Product Lifecycle Management (PLM) system by updating and aligning Quality Management System (QMS) documentation. This role will work closely with project managers and cross-functional teams to ensure procedures, work instructions, training materials, and quality documentation accurately reflect new business processes introduced through the PLM implementation.

This is an excellent opportunity for someone with strong technical writing skills, experience in regulated environments, and familiarity with quality systems and documentation.

Key Responsibilities

• Review and update Quality Management System (QMS) documentation, including SOPs, work instructions, forms, templates, and procedures impacted by the new PLM system.
• Rewrite and reorganize documentation to align with updated workflows, system functionality, and quality requirements.
• Ensure documentation complies with applicable regulatory, quality, and internal standards.
• Collaborate with process owners, subject matter experts (SMEs), and cross-functional teams to validate documentation accuracy and consistency.
• Support document change control activities to ensure documentation is approved and released prior to system go-live.
• Partner with the PLM implementation team to understand new system functionality and translate technical processes into clear, user-friendly documentation.
• Assist with User Acceptance Testing (UAT), including developing test scripts, documenting test results, tracking defects, and supporting issue resolution.
• Create and update training materials such as job aids, quick reference guides, SOP walkthroughs, presentations, and other learning resources.
• Support onboarding and training initiatives by gathering feedback and providing clarification on new processes.

Qualifications

• Bachelor's degree in Science, Engineering, Business, or a related field.
• Experience maintaining or updating Quality Management System (QMS) documentation.
• Experience working in a regulated industry such as medical devices, pharmaceuticals, biotechnology, or other FDA-regulated environments preferred.
• Familiarity with Product Lifecycle Management (PLM) systems.
• Strong technical writing, editing, and documentation skills.
• Experience supporting User Acceptance Testing (UAT) or developing test scripts is preferred.
• Ability to simplify complex processes into clear, easy-to-follow documentation.
• Excellent communication and collaboration skills with the ability to work effectively across multiple functional teams.
• Strong organizational skills with exceptional attention to detail.
• Ability to manage multiple priorities while working independently.

Preferred Experience

• Knowledge of cGMP, cGDP, and 21 CFR Part 11 regulations.
• Experience supporting system implementations or process improvement initiatives.
• Background developing training documentation or end-user learning materials.
• Customer service or stakeholder management experience.

The ideal candidate is a detail-oriented technical documentation professional who enjoys improving quality systems, collaborating with cross-functional teams, and helping organizations successfully implement new technologies through clear documentation and effective training materials.