Document Control Specialist

Talentify; Irvine (CA); On-site; USD 32,000 - 34,000; Full time

Job summary

Talentify in Irvine, CA is seeking a Document Control Specialist to manage engineering and product development records, ensure GDP compliance, and support quality systems across the product lifecycle. You'll collaborate with Engineering, Quality, Regulatory, and Manufacturing to drive document reviews and training records.

This onsite role focuses on document workflows in an electronic document management system, change requests, templates, and archival processes.

Qualifications

• High school diploma or equivalent.
• 2+ years of experience in dental or medical device industry.
• 1+ year of customer service experience.
• Proficient in MS Office Suite (Word, PowerPoint, Outlook); advanced Excel.
• Knowledge of document control fundamentals, quality systems, GMP requirements.
• Understanding of current medical device industry and applicable regulations.

Responsibilities

• Maintains and controls Engineering and Product Development records for integrity and accessibility.
• Processes and controls storage of Quality Records.
• Interacts with users to ensure conformance to quality control requirements.
• Manages review workflows in the electronic document management system.
• Ensures document formats comply with Good Documentation Practices (GDPs).
• Assists in FDA inspections and Notified Body audits as needed.
• Tracks timely document review and implementation.
• Distributes documents per control procedures.
• Inputs data accurately and maintains database with self-audit checks.
• Analyzes change requests for completeness.
• Provides documentation support to internal customers.
• Updates document profiles with changes.
• Provides clerical support for documentation processes and systems.
• Creates and maintains document templates and uploads into EDMS.
• Routes and releases documentation.
• Monitors training requirements to ensure SOP compliance.
• Maintains Document Control email inbox and coordinates with team.
• Maintains document archival room for easy retrievability.
• Assists with training materials and training records.
• Collaborates with internal teams to obtain training materials.
• Performs other related duties as needed.

Skills

MS Office Suite

Excel (advanced)

Document control

Quality systems

GMP

Medical device regulations

Tools

EDMS

Job description

We're looking for a Document Control Specialist to help keep our product development and quality systems running smoothly.u00A0

You'll manage the documents that support our products throughout their lifecycleu2014ensuring 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 departmentu2019s standard operating procedures.u00A0
• 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.