Change Control Coordinator

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

Dandy is hiring a Change Control Coordinator to join our rapidly growing venture-backed company. The Change Control Coordinator own the change control process}. In this role, You will play a key role in ensuring that Quality Systems across our U.S. manufacturing sites adheres to regulatory requirements including ISO 13485, MDSAP, and future compliance with EU MDR/IVDR.

What You'll Do

• eQMS Change Control Management:

  • Administer the change control process from initiation to closure within the new eQMS platform (Dot Compliance).

  • Serve as a Subject Matter Expert (SME) for the eQMS change control module, providing user support and training to all departments.

  • Ensure all Change Requests (CRs) are properly documented with clear justification, risk and impact assessments, and verification/validation plans.

  • Route change packages for review and approval by required stakeholders, tracking progress and facilitating timely completion.

  • Support Document Control creation and routing.

• MDSAP & Regulatory Compliance:

  • Ensure the change control process and associated records rigorously adhere to the requirements of MDSAP participating authorities, FDA QSR, and ISO 13485.

  • Assist in generating reports, metrics, and dashboards from the eQMS to monitor change control performance and compliance.

  • Support internal and external audits (e.g., FDA, Notified Body, MDSAP Auditing Organizations) by retrieving change control records and providing clear explanations of the process.

• eQMS Implementation & Adoption Support:

  • Collaborate with the eQMS project team on activities related to the change control module, including user acceptance testing (UAT) and data migration.

  • Assist in the development and revision of Standard Operating Procedures (SOPs), Work Instructions (WIs), and training materials for the new electronic change control process.

  • Act as a change champion, promoting user adoption and highlighting the benefits of the new eQMS for managing change.

• Cross-Functional Collaboration:

  • Work closely with Engineering, Manufacturing, Regulatory Affairs, R&D, and Supply Chain to assess the impact of proposed changes.

  • Coordinate and facilitate Change Control Board (CCB) meetings, ensuring agendas are clear, discussions are productive, and decisions are accurately documented.

  • Communicate the status of active changes to relevant stakeholders to ensure awareness and alignment on implementation activities.

What We're Looking For

• Bachelor’s degree in a Life Science, Engineering, or a related technical field. (An Associate's degree with significant, directly relevant experience may be considered).

• 1-3 years of experience in a Quality Assurance or related role within the medical device industry.

• Direct, hands-on experience with a formal change control process.

• Strong working knowledge of Quality Management System regulations and standards, specifically FDA 21 CFR Part 820 and ISO 13485.

• Exceptional attention to detail, organizational skills, and the ability to manage multiple priorities simultaneously.

• Excellent written and verbal communication skills.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or G-suites.

Bonus Points For

• Experience working directly within an electronic Quality Management System (eQMS) platform (e.g., MasterControl, Veeva QualityDocs, TrackWise Digital, Greenlight Guru).

• Direct involvement in an eQMS implementation or migration project.

• Demonstrated understanding of MDSAP structure and its requirements for change management.

• Experience participating in or supporting regulatory audits.

• Ability to interpret technical information, drawings, and specifications to assess the impact of changes.

The reasonably estimated salary for this role at Dandy is $63,000 - $70,000 plus equity. Actual compensation is based on a number of factors including, but not limited to the primary work location, candidate's skills, qualifications, and experience.

Req ID: J-794

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!