Onsite Document Control Specialist (Medical Devices)

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

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.