Document Control Specialist

\u003cp style=\"min-height:1.5em\"\u003eDandy 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.\u003c/p\u003e\u003cp style=\"min-height:1.5em\"\u003cstrong\u003eAbout the Role\u003c/strong\u003e\u003c/p\u003e\u003cp style=\"min-height:1.5em\"\u003eWe 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.\u003c/p\u003e\u003cp style=\"min-height:1.5em\"\u003cstrong\u003eKey Responsibilities\u003c/strong\u003e\u003c/p\u003e\u003cul style=\"min-height:1.5em\"\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eOwn and manage the lifecycle of controlled quality documents (SOPs, Work Instructions, Forms, Records, etc.)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eMaintain document control processes that align with ISO 13485, MDSAP, and FDA 21 CFR Part 820\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eSupport future expansion of the QMS to meet EU MDR/IVDR documentation requirements (e.g., Technical Files, DHFs)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eControl issuance, revision, approval, and obsolescence processes for quality documentation across multiple sites\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eSupport internal, supplier, and regulatory audits by ensuring document readiness, version control, and retrieval\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eEnsure training records and document change controls are traceable and compliant with applicable standards\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003ePartner with cross-functional teams to implement changes, release documents, and ensure timely training\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eAssist the QMS Manager in harmonizing site-level documentation and driving best practices in documentation structure\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eMaintain documentation logs, training matrices, and controlled document access (physical and digital)\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp style=\"min-height:1.5em\"\u003e\u003cstrong\u003eRequirements\u003c/strong\u003e\u003c/p\u003e\u003cul style=\"min-height:1.5em\"\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003e3+ years of document control experience in the medical device, biotech, or pharma industry\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eWorking knowledge of ISO 13485, MDSAP, and FDA 21 CFR Part 820\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eFamiliarity with document requirements related to EU MDR/IVDR or willingness to learn\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eExperience with eQMS platforms or structured document management systems (e.g., MasterControl, Veeva, Greenlight Guru, or Google Drive-based control systems)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eStrong attention to detail, organizational, and communication skills\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eAbility to work independently across departments and time zones\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eProficiency in Google Workspace or Microsoft Office\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp style=\"min-height:1.5em\"\u003e\u003cstrong\u003ePreferred Qualifications\u003c/strong\u003e\u003c/p\u003e\u003cul style=\"min-height:1.5em\"\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eExperience supporting a multi-site QMS (e.g., Utah and Dallas etc operations)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eExposure to audit readiness activities for ISO or MDSAP audits\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eFamiliarity with document requirements for Notified Body or European regulatory submissions\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eKnowledge of training compliance workflows and document change tracking\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eAssociate or Bachelor’s degree preferred but not required\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp style=\"min-height:1.5em\"\u003e\u003cstrong\u003eWhy Join Us?\u003c/strong\u003e\u003c/p\u003e\u003cul style=\"min-height:1.5em\"\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eHelp build a world-class QMS as we grow and expand into international markets\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eWork closely with experienced leaders focused on operational excellence and regulatory readiness\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eGain exposure to global regulatory frameworks including MDSAP and EU MDR\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp style=\"min-height:1.5em\"\u003eCompetitive salary, benefits, and career development opportunities\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp style=\"min-height:1.5em\"\u003eFor 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.\u003c/p\u003e\u003cp style=\"min-height:1.5em\"\u003eDandy 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.\u003c/p\u003e\u003cp style=\"min-height:1.5em\"\u003eDandy 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 \u003ca target=\"_blank\" rel=\"noopener noreferrer nofollow\" href=\"https://www.meetdandy.com/careers/\"\u003eDandy Careers\u003c/a\u003e for more! \u003c/p\u003e