Document Control Specialist

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 31,684 - 34,440; Full time

Job summary

Prismatik Dentalcraft, a Glidewell Dental division in Irvine, seeks a Document Control Specialist to manage product development records and quality systems. You will ensure documents are accurate, compliant, and accessible for engineering, quality, regulatory, and manufacturing teams.

You will drive document reviews, change requests, training records, and GDP/GMP adherence, while supporting FDA inspections and Notified Body audits as needed.

Qualifications

• High school diploma or equivalent required.
• Minimum two years in dental or medical device industry.
• Minimum one year customer service experience.
• Proficient with MS Office; advanced Excel.
• Knowledge of document control, quality systems, GMP requirements.
• Understanding of medical device regulations.

Responsibilities

• Maintain all Engineering and Product Development records for integrity and accessibility.
• Process and control storage of Quality Records.
• Interact with users to ensure conformance to quality control requirements.
• Manage review workflows in the electronic document management system.
• Ensure GDP/GMP compliance in document formats.
• Assist in FDA inspections and Notified Body audits as requested.
• Track and facilitate timely document reviews and implementations.
• Distribute documents per control procedures.
• Input data accurately and maintain database entries.

Skills

Customer service

Attention to detail

Communication

Education

High school diploma or equivalent

Tools

MS Office Suite (Word, PowerPoint, Outlook)

Excel (advanced)

Job description

Prismatik Dentalcraft is a division of Glidewell Dental

We're looking for a Document Control Specialist to help keep our product development and quality systems running smoothly.

You'll manage the documents that support our products throughout their lifecycle- ensuring they're accurate, compliant, and available when teams need them. Working closely with Engineering, Quality, Regulatory, and Manufacturing, you'll help drive document reviews, change requests, training records, and quality system processes that keep product development on track.

Essential Functions

• Maintains all Engineering and Product Development records to ensure integrity and accessibility including but not limited to photocopying and scanning documents.
• Processes and controls storage of Quality Records.
• Interacts directly with users of controlled documentation to ensure internal conformance to company quality control requirements.
• Processes review and approval workflows in electronic document management system.
• Reviews document format to ensure compliance to Good Documentation Practices (GDPs).
• Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding marketed products, as requested.
• Tracks and facilitates timely documentation review and implementation.
• Distributes documents in accordance to control procedures.
• Ensures accurate and timely input of database entries; implements a self-auditing system to verify work.
• Analyzes change requests for completeness.
• Provides support to internal customers with documentation needs.
• Updates electronic document profiles to reflect appropriate changes.
• Provides clerical and administrative support related to documentation processes and systems.
• Creates and maintains document templates by coding fields and uploading into the electronic document management system.
• Routes and releases documentation.
• Follows up on training requirements to ensure compliance to the department’s standard operating procedures.
• Assists with monitoring the Document Control email inbox to ensure all requests are assigned and responded to in a timely manner. Communicates among the Document Control team to ensure request are fully completed.
• Maintains the document archival room; ensures files are accurate and easily retrievable.
• Assists with training program by filing training records and logging training.
• Works with a variety of internal teams to ensure receipt of training materials.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications

• High school diploma or equivalent.
• Minimum two (2) years of experience in dental or medical device industry.
• Minimum one (1) year of customer service experience.
• Proficient skills in the MS Office Suite (Word, PowerPoint, and Outlook); advanced proficiency in Excel.
• Demonstrated knowledge of document control fundamentals, quality systems, and Good Manufacturing Practice (GMP) requirements.
• Demonstrated understanding of current medical device industry and applicable regulations.

Pay range: $23.00 to $25.00/hr

Exact compensation may vary based on skills and experience.

This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.