Documentation Specialist

Hiring: Quality Systems Analyst| Santa Ana, CA (Onsite)

We are hiring a Quality Systems Analyst to support a leading medical device company on a 6+ month contract. This is a great opportunity for candidates with documentation, change control, and PLM experience in a regulated environment.

Location: Santa Ana, CA (Onsite)

Duration: 6+ Months Contract

Role Overview

This role focuses on document management and change control activities to support a new manufacturing site. You will work closely with cross-functional and global teams to ensure accurate and compliant documentation.

Key Responsibilities

• Create and manage Change Requests/Notices in PLM systems
• Perform document updates and redlining (MS Word)
• Route changes through approval workflows
• Coordinate with internal and global teams for documentation updates
• Ensure compliance with FDA and ISO 13485 standards

Required Skills

• Experience in documentation / change control
• Exposure to regulated industries (medical device preferred)
• Strong attention to detail and process adherence
• Proficiency in MS Office (Word, Excel)
• Good communication and coordination skills

Nice to Have

• Experience with PLM systems (Windchill, SAP, ETQ, etc.)
• Knowledge of ISO 13485
• Medical device industry experience

Ideal Candidate

Someone who is detail-oriented, process-driven, and comfortable working in a documentation-heavy, compliance-focused role