Document Control Specialist

United States

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$63,000 – $70,000Compensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Dental, Medical Devices, BiotechnologyIndustries

Requirements

Candidates must have over 3 years of document control experience in the medical device, biotech, or pharma industry, with a working knowledge of ISO 13485, MDSAP, and FDA 21 CFR Part 820. Familiarity with EU MDR/IVDR document requirements or a willingness to learn is necessary, along with experience using eQMS platforms or structured document management systems. Strong attention to detail, organizational skills, communication skills, and the ability to work independently across departments and time zones are essential. Proficiency in Google Workspace or Microsoft Office is required.

Responsibilities

The Document Control Specialist will manage the lifecycle of controlled quality documents, including SOPs, Work Instructions, Forms, and Records. They will maintain document control processes aligned with ISO 13485, MDSAP, and FDA 21 CFR Part 820, and support the integration of EU MDR/IVDR documentation requirements. Key duties include controlling the issuance, revision, approval, and obsolescence of quality documentation, supporting audits by ensuring document readiness, and verifying the traceability and compliance of training records and document change controls. The specialist will also partner with cross-functional teams to implement changes, release documents, ensure timely training, harmonize site-level documentation, and maintain documentation logs, training matrices, and controlled document access.

Skills

Document Control

Quality Management System (QMS)

ISO 13485

MDSAP

FDA 21 CFR Part 820

EU MDR/IVDR

Technical Files

Design History Files (DHFs)

Document Lifecycle Management

Version Control

Audit Support

Training Records

Document Change Control

Cross-functional Collaboration

Dandy

Digital dental lab services and software

About Dandy

Dandy provides digital dentistry solutions to dental practices across the United States, enabling them to transition from traditional methods to modern digital techniques. Their services include digital scanning, design, and manufacturing of dental prosthetics such as dentures and implants. Dandy's proprietary Chairside software simplifies the scanning process, allowing dental professionals to perform complex procedures with greater accuracy and efficiency. Unlike competitors, Dandy offers their Chairside software for free, making it easier for practices to scan patients and submit lab cases. The company generates revenue through the manufacturing and sale of dental products based on these digital scans, along with providing clinical support and live scan feedback. Dandy's goal is to enhance patient experiences and improve operational efficiency for dental practices by facilitating the adoption of digital dentistry.

New York City, New YorkHeadquarters

2020Year Founded

$4.2MTotal Funding

SEEDCompany Stage

Enterprise Software, HealthcareIndustries

1,001-5,000Employees

Benefits

Medical, dental, & vision coverage

Parental planning

Mental health benefits

401(k) plan

PTO

Fitness reimbursements

Risks

Competition from established companies like Align Technology is increasing.

Data privacy concerns are rising with digitalization in the dental industry.

Rising raw material costs could impact Dandy's profit margins.

Differentiation

Dandy offers a unique end-to-end digital dental lab service.

Their Chairside software simplifies the scanning process for dental professionals.

Dandy provides free software, earning revenue from dental prosthetics sales.

Upsides

Growing demand for digital dental solutions aligns with Dandy's offerings.

Personalized dental care trend supports Dandy's customized prosthetics services.

AI integration in dental imaging complements Dandy's digital scanning technology.

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