What are the responsibilities and job description for the Quality Systems Specialist (Medical Device) position at Dandy?
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
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!
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.
- Assist in the planning, execution, and follow-up of internal and external audits, including MDSAP, ISO 13485, and FDA inspections.
- Manage and track non-conformances and corrective/preventive actions (CAPAs) resulting from audits to ensure timely and effective closure.
- Monitor changes in relevant regulations (e.g., FDA 21 CFR 820, ISO 13485, MDSAP) and assist in updating QMS procedures accordingly.
- eQMS Implementation & Support:
- Serve as a key resource for the organization-wide rollout of our eQMS platform (e.g., MasterControl, Veeva, etc.).
- Develop and deliver training materials to onboard users at various facilities, ensuring a smooth transition from paper-based or legacy systems.
- Provide ongoing technical support and troubleshooting for eQMS users across the organization.
- Collaborate with site leaders to configure eQMS modules (e.g., Document Control, CAPA, Training, Audit Management) to align with harmonized global processes.
- Assist with data migration activities and perform verification to ensure data integrity.
- General Quality System Duties:
- Support the administration of core quality system elements, including document control, CAPA, internal audits, and management review preparation.
- Analyze quality data and generate reports to identify trends and support data-driven decision-making.
- Promote a culture of quality and compliance throughout the organization.
- Required:
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- A minimum of 3-5 years of experience in a Quality Assurance or Quality Systems role within the medical device industry.
- Demonstrated, hands-on experience participating in or directly supporting MDSAP audits.
- Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820.
- Prior experience working with an eQMS platform (e.g., MasterControl, Veeva, Greenlight Guru, Dot Compliance).
- Excellent communication, training, and interpersonal skills with the ability to work effectively with cross-functional teams.
- Preferred:
- ASQ certification (e.g., CQA, CQE) is a plus.
- 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
- 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!
