Document Control Coordinator

Document Control & Quality Systems Coordinator | Remote | Contract (Full-Time)

Hiring Immediately

About the Role

A medical device company is seeking an experienced Document Control & Quality Systems Coordinator to join their team on a full-time contract basis. This is a fully remote, immediate-start opportunity for a detail-oriented quality professional who thrives in a fast-paced, regulated environment. The ideal candidate is hands-on, self-sufficient, and comfortable owning document control and quality system activities with minimal ramp-up time.

Compensation: $30--$34/hour Schedule: Full-time, 40 hours/week Location: Fully Remote Start: Immediate

Key Responsibilities

• Manage and maintain the electronic document management system (eDMS) including document creation, revision, review, approval, release, and obsolescence workflows
• Serve as the day-to-day administrator of MasterControl or comparable eDMS platform
• Support the CAPA program by maintaining the CAPA log, tracking open actions, and assisting owners with documentation and timely closure
• Manage open Nonconformance Material Reports (NCMRs) through to closure, coordinating with cross-functional stakeholders as needed
• Support supplier quality processes including vendor qualification documentation and quality agreement maintenance
• Create, format, and maintain controlled quality documents including SOPs, work instructions, and forms using Microsoft Word and Excel
• Ensure all documentation practices align with FDA regulations, ISO standards, and Good Documentation Practices (GDP)
• Collaborate with Quality, Operations, Regulatory Affairs, and Supply Chain teams to support day-to-day quality system needs
• Assist with internal audit preparation and support external audit readiness activities as needed
• Identify and escalate documentation gaps or quality system issues proactively

Qualifications

• 2--5 years of experience in document control or quality systems within a medical device, pharmaceutical, or life sciences environment
• Hands-on proficiency with MasterControl preferred; experience with comparable eDMS platforms (Veeva, ETQ, Greenlight Guru) considered
• Strong working knowledge of Microsoft Word and Excel including formatting, document revision, and basic data tracking
• Familiarity with CAPA processes --- experience maintaining a CAPA log or supporting CAPA investigations a plus
• Experience managing NCMRs and nonconformance documentation
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and Good Documentation Practices
• Exposure to supplier quality processes and vendor qualification documentation a plus
• Strong attention to detail, highly organized, and able to manage multiple priorities independently in a remote environment
• Excellent written and verbal communication skills

Nice to Have

• ASQ certification (CQA, CQIA, or equivalent)
• Experience supporting FDA or ISO audits
• Familiarity with supplier corrective action (SCAR) processes