Document Control Specialist

VDYNE is a clinical-stage medical device company focused on developing innovative transcatheter valve solutions for tricuspid regurgitation (TR), a life-threatening condition. With its patented side-delivery technology, VDYNE enables minimally invasive procedures, expanding treatment options for TR patients. Headquartered in Minneapolis, Minnesota, VDYNE is actively conducting clinical studies across the United States, Europe, and Australia.

THE ROLE

As a Document Control Specialist at VDyne, you'll be the backbone of our Quality Management System — ensuring that controlled documents are accurate, accessible, compliant, and audit-ready at all times. You'll work closely with Quality, Engineering, Manufacturing, Clinical, and Regulatory Affairs teams, serving as the go-to resource for document routing, change management, records management, and QMS administration.

This role is ideal for someone who is highly organized, detail-oriented, and takes genuine pride in the kind of rigorous documentation work that keeps a regulated medical device company running smoothly.

WHAT YOU LL DO

• Process controlled documents through the electronic Quality Management System (eQMS) including preparation, routing, review, approval, release, and archival
• Assign document numbers, maintain revision histories, and ensure controlled copies are distributed correctly
• Process document changes through the Change Order system and coordinate routing of document packages for review and approval
• Maintain quality records ensuring they are legible, traceable, protected, and retrievable
• Support internal, supplier, notified body, and regulatory audits and inspections including retrieval of requested documentation
• Assist with CAPA and audit remediation activities related to documentation
• Support document-related training, training record maintenance, and training completion verification
• Identify and recommend process improvements to increase accuracy and efficiency across document control operations

WHAT WE RE LOOKING FOR

Required

• 3–7 years of experience in document control within a medical device manufacturing environment
• Working knowledge of ISO 13485:2016 and FDA QMSR (21 CFR Part 820) requirements
• Experience with eQMS tools, Microsoft Office, and Adobe Pro
• Excellent attention to detail with a high degree of accuracy in documentation and record management
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment
• Excellent written and verbal communication skills

Preferred

• Experience supporting Class II or Class III medical devices
• Familiarity with Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR)
• Experience supporting audits and inspections
• Knowledge of document lifecycle management

WHAT MAKES THIS ROLE DIFFERENT

You ll be joining a small, collaborative quality team at a company where the work you do has a direct line to patient safety and clinical program success. At VDyne, document control isn t a back-office function — it s a critical part of how we maintain the integrity of our QMS and stay inspection-ready as we advance through clinical studies and toward commercialization.

Your contributions will be visible and valued from day one.

VDYNE is an equal opportunity employer.

We celebrate diversity and are committed to creating an inclusive environment for all employees.