Job Description:

Seeking a Document Control Analyst to support Quality Management System (QMS) documentation and records throughout the product lifecycle—from concept through obsolescence—in a fast-paced, highly regulated environment. This role involves creating, releasing, and managing documentation (SOPs, work instructions, validation records, etc.) in accordance with FDA and ISO 13485 standards. The analyst will work cross-functionally with Operations, Supply Chain, Engineering, and Compliance teams to ensure controlled document processes, regulatory readiness, and audit support.

Key Responsibilities:

• Develop, release, and maintain quality system documents and records.
• Ensure proper document version control, access, and compliance with applicable regulations (FDA, ISO 13485, CFR Part 11).
• Support implementation and maintenance of electronic QMS (eQMS) platforms.
• Assist in audit readiness and submissions for regulatory and licensure compliance.
• Collaborate across departments to drive documentation best practices and system improvements.

Qualifications:

• 5+ years managing QMS documentation in a medical device or regulated environment.
• Strong understanding of FDA regulations, ISO 13485, and CFR Part 11.
• Experience with document management or PLM systems (e.g., Teamcenter).
• Proficiency with Google Suite and attention to detail in documentation practices.
• Strong organizational and project management skills with minimal supervision required.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.