QMS Integration Specialist

Job Summary

Supporting the integration of products and quality processes into the Quality Management System (QMS), the remote QMS Integration Specialist will perform gap assessments, develop controlled documentation, and facilitate the transition to a future-state QMS over an 18-month contract.

Key Responsibilities

• Conduct detailed assessments of existing procedures and documentation to identify gaps and recommend necessary actions
• Draft and revise controlled QMS documentation, ensuring clarity and compliance with regulatory requirements
• Coordinate document control activities and support the implementation of revised processes for effective deployment

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Technical Communication, or a related field, or equivalent experience
• 3+ years of experience in Quality Systems or QMS technical writing within a regulated industry
• Proven experience in writing and revising SOPs, work instructions, and other controlled documentation
• Working knowledge of Quality Management Systems and regulated documentation practices
• Ability to evaluate existing processes and translate requirements into practical documentation