Document Control Specialist

Summary

Join Dandy's Quality team as a detail-oriented Document Control Specialist and contribute to the development and maintenance of a compliant and scalable Quality Management System (QMS). You will ensure that documentation across U.S. manufacturing sites adheres to regulatory requirements, including ISO 13485, MDSAP, and future compliance with EU MDR/IVDR. This key role involves managing the lifecycle of controlled quality documents, maintaining document control processes, and supporting internal and external audits. You will partner with cross-functional teams, implement changes, and ensure timely training. The position requires experience in document control within the medical device, biotech, or pharma industry, along with knowledge of relevant regulatory standards. Dandy offers competitive salary, benefits, and career development opportunities.

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

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)

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

Benefits

• Competitive salary, benefits, and career development opportunities
• Healthcare
• Dental
• Mental health support
• Parental planning resources
• Retirement savings options
• Generous paid time off