Quality Systems Specialist (Medical Device)

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 Quality System 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 Quality Systems across our U.S. manufacturing sites adheres to regulatory requirements including ISO 13485, MDSAP, and future compliance with EU MDR / IVDR.

Key Responsibilities

• MDSAP & Regulatory Compliance

Act as a subject matter expert for MDSAP requirements, ensuring the QMS remains in a constant state of audit readiness.

Serve as a key resource for the organization-wide rollout of our eQMS platform (e.g., MasterControl, Veeva, etc.).

Support the administration of core quality system elements, including document control, CAPA, internal audits, and management review preparation.

Qualifications & Skills

Bachelor's degree in Engineering, Life Sciences, or a related technical field.

ASQ certification (e.g., CQA, CQE) is a plus.

Why Join Us?

Req ID : J-773

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!

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