Job Description: Document Control Specialist

Salary: $63K - $70K Location Type: Remote Employment Type: Full-Time

Company Overview

Dandy is revolutionizing the dental industry, a sector valued at over $200 billion. With support from leading venture capital firms, we are dedicated to modernizing dental practices through technology. Our mission is to create the operating system for dental offices worldwide, equipping clinicians and their teams with innovative technology and exceptional support to enhance their practices, people, and patients.

About the Role

We are seeking a meticulous Document Control Specialist to join our Quality team. This role is crucial for developing and maintaining a compliant and scalable Quality Management System (QMS). You will be instrumental in ensuring that documentation across our U.S. manufacturing sites meets regulatory standards, including ISO 13485, MDSAP, and upcoming EU MDR/IVDR requirements.

Key Responsibilities

• Document Lifecycle Management: Own and manage the complete lifecycle of controlled quality documents such as SOPs, Work Instructions, Forms, and Records.
• QMS Alignment: Maintain document control processes in accordance with ISO 13485, MDSAP, and FDA 21 CFR Part 820.
• Future Compliance: Support the expansion of the QMS to meet EU MDR/IVDR documentation needs, including Technical Files and Design History Files (DHFs).
• Document Control Processes: Manage the issuance, revision, approval, and obsolescence of quality documentation across multiple sites.
• Audit Support: Facilitate internal, supplier, and regulatory audits by ensuring document readiness, proper version control, and efficient retrieval.
• Training and Change Control: Ensure traceability and compliance of training records and document change controls with applicable standards.
• Cross-functional Collaboration: Partner with various teams to implement changes, release documents, and ensure timely training completion.
• Documentation Harmonization: Assist the QMS Manager in harmonizing site-level documentation and promoting best practices in document structure.
• Record Maintenance: Maintain documentation logs, training matrices, and controlled document access (both physical and digital).

Requirements

• Experience: 3+ years of document control experience in the medical device, biotech, or pharmaceutical industry.
• Regulatory Knowledge: Working knowledge of ISO 13485, MDSAP, and FDA 21 CFR Part 820.
• EU MDR/IVDR Familiarity: Experience with EU MDR/IVDR documentation requirements or a strong willingness to learn.
• eQMS Experience: Proficiency with eQMS platforms or structured document management systems (e.g., MasterControl, Veeva, Greenlight Guru, or Google Drive-based control systems).
• Skills:
  • Strong attention to detail.
  • Excellent organizational and communication skills.
  • Ability to work independently across departments and time zones.
  • Proficiency in Google Workspace or Microsoft Office.

Preferred Qualifications

• Experience supporting a multi-site QMS (e.g., Utah and Dallas operations).
• Exposure to audit readiness activities for ISO or MDSAP audits.
• Familiarity with document requirements for Notified Body or European regulatory submissions.
• Knowledge of training compliance workflows and document change tracking.
• An Associate or Bachelor’s degree is preferred but not required.

Why Join Us?

• QMS Development: Contribute to building a world-class QMS as we expand internationally.
• Mentorship: Work closely with experienced leaders focused on operational excellence and regulatory readiness.
• Global Exposure: Gain insights into global regulatory frameworks, including MDSAP and EU MDR.
• Compensation & Benefits: Competitive salary, comprehensive benefits, and opportunities for career development.

Benefits

Dandy offers a wide range of best-in-class, comprehensive, and inclusive benefits for full-time positions, tailored to each country of operation. These typically include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off.

Equal Opportunity Employer

Dandy is proud to be an equal-opportunity employer. We are committed to fostering a diverse and inclusive culture that celebrates authenticity and teamwork. We do not discriminate based on race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, or disability.