Document Controller (Temp/Part-Time)

Part-Time/Temporary Document Control Specialist - Medical Device

Looking for a flexible Role, where you can say you were part of a revolutionary product!
Passionate about quality and compliance in the medical device space?

MCS are working exclusively with an innovative AI-driven medical device company seeking a Part-Time Document Control Specialist to support their Quality Management System (QMS) and ensure compliance standards are met!

This is an exciting opportunity to work in a fast-paced startup environment, managing eQMS processes (Orcanos), supporting audits, and playing a key role in regulatory compliance.

The Role

🔹 Document Control & Compliance

• Maintain and manage controlled documents within Orcanos eQMS
• Oversee document review, approval workflows, and version control
• Ensure policies, procedures, and work instructions are properly distributed
• Process document change requests (DCRs) and engineering change orders (ECOs)
• Ensure compliance with ISO 13485, FDA QSR (21 CFR Part 820), and MDR
• Support internal audits by organizing and retrieving documentation

What You Need:

• Experience in medical device document control within a QMS environment
• Familiarity with ISO 13485, FDA 21 CFR Part 820, and MDR
• Strong attention to detail and ability to work efficiently in a startup
• Proficiency in Microsoft Office (Word, Excel, Outlook)

What's in it for you?

1. Competitive hourly rate
2. Part-time, flexible schedule (20-25 hours per week)
3. Remote-first role, with occasional on-site meetings if needed
4. Work with cutting-edge medical technology in a high-growth environment

If this sounds like an exciting challenge, and offers you the flexibility you require, click apply. or email your resume to d.crawford@mcsgroup.jobs

Desired Skills and Experience

Medical Device, Document Control, QMS, ISO 13485, FDA 21 CFR Part 820, MDR, eQMS, Orcanos, Change Management, Document Review, Version Control, Compliance, Audit Support, Risk Management, ISO 14971, Design Control, Regulatory Documentation, Quality Assurance, SOPs, Training Coordination, Microsoft Office, FDA QSR, Process Improvement, Startup Environment, Medical Device Startups, Engineering Change Orders (ECOs), Document Change Requests (DCRs)