Document Control Specialist

Dandy is transforming the massive and antiquated dental industry—an industry worth over $200B. Backed by some of the world’s leading venture capital firms, we’re on an ambitious mission to simplify and modernize every function of the dental practice through technology. As we expand our reach globally, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams with technology, innovation, and world-class support to achieve more for their practices, their people, and their patients.

About the Role

We are seeking a detail-oriented Document Control Specialist to join our Quality team and support the development and maintenance of a compliant and scalable Quality Management System (QMS). You will play a key role in ensuring that documentation across our U.S. manufacturing sites adheres to regulatory requirements including ISO 13485, MDSAP, and future compliance with EU MDR/IVDR.

Key Responsibilities

• Own and manage the lifecycle of controlled quality documents (SOPs, Work Instructions, Forms, Records, etc.)

• Maintain document control processes that align with ISO 13485, MDSAP, and FDA 21 CFR Part 820

• Support future expansion of the QMS to meet EU MDR/IVDR documentation requirements (e.g., Technical Files, DHFs)

• Control issuance, revision, approval, and obsolescence processes for quality documentation across multiple sites

• Support internal, supplier, and regulatory audits by ensuring document readiness, version control, and retrieval

• Ensure training records and document change controls are traceable and compliant with applicable standards

• Partner with cross-functional teams to implement changes, release documents, and ensure timely training

• Assist the QMS Manager in harmonizing site-level documentation and driving best practices in documentation structure

• Maintain documentation logs, training matrices, and controlled document access (physical and digital)

Requirements

• 3+ years of document control experience in the medical device, biotech, or pharma industry

• Working knowledge of ISO 13485, MDSAP, and FDA 21 CFR Part 820

• Familiarity with document requirements related to EU MDR/IVDR or willingness to learn

• Experience with eQMS platforms or structured document management systems (e.g., MasterControl, Veeva, Greenlight Guru, or Google Drive-based control systems)

• Strong attention to detail, 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 etc 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

• Associate or Bachelor’s degree preferred but not required

Why Join Us?

• Help build a world-class QMS as we grow and expand into international markets

• Work closely with experienced leaders focused on operational excellence and regulatory readiness

• Gain exposure to global regulatory frameworks including MDSAP and EU MDR

• Competitive salary, benefits, and career development opportunities

For full-time positions, Dandy offers a wide range of best-in-class, comprehensive, and inclusive benefits tailored to each country where we operate. Our local benefits packages typically include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off—ensuring our team members are supported no matter where they live and work.

Dandy is proud to be an equal-opportunity employer. We are committed to building a diverse and inclusive culture that celebrates authenticity to win as one. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, citizenship or immigration status, or any other legally protected characteristics.

Dandy also fully complies with the Americans with Disabilities Act (ADA). We are dedicated to embracing challenges and creating an accessible, inclusive workplace for all individuals. If you require any accommodations for your interview or have any questions beforehand, rest assured that we will do everything we can to meet your needs. Visit Dandy Careers for more!

Compensation Range: $63K - $70K