Medical Device Document Control Specialist – QA

huMannity Medtec; Santa Clarita (CA); On-site; USD 48,000 - 52,000; Full time

Benefits offered by this job

9/80 schedule

Long weekends annually

Work-life balance

Job summary

huMannity Medtec is seeking a detail-oriented Document Control Specialist to join our Quality Assurance team in Santa Clarita, CA. You will administer and maintain controlled documents, training records, and document control systems to meet quality standards.

The role requires 3+ years in a regulated environment, strong editing skills, and experience with eDMS and ERP systems. You will collaborate with Engineering, Manufacturing, and R&D to ensure timely document changes and CGMB participation.

Qualifications

• 3+ years in document control or quality systems in medical devices or a regulated environment.
• Advanced proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Visio).
• Experience with electronic document management systems (eDMS) and ERP systems.
• Ability to review drawings, procedures, specifications for document control compliance.
• Experience creating and editing documentation to established templates and procedures.

Responsibilities

• Manage controlled documents, records, and document control systems per company procedures and quality requirements.
• Review documents for completeness, accuracy, formatting, and standard compliance.
• Edit documents for formatting, grammar, and data consistency.
• Process change requests and create change orders promptly.
• Coordinate with Engineering, Manufacturing, Quality, and R&D to finish document changes on time.
• Monitor document workflows and follow up on outstanding actions.
• Maintain document logs and records for data integrity and traceability.
• Support Change Control Board (CCB) meetings and change management activities.
• Conduct periodic document reviews and ensure adherence to schedules.
• Compile metrics, generate reports, and maintain KPI dashboards.
• Assign training requirements and ensure training completion; maintain matrices.

Skills

Attention to detail

Organizational skills

Communication

Problem solving

Independent worker

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Visio

eDMS

ERP systems

Job description

huMannity Medtec is seeking a detail-oriented Document Control Specialist to join our Quality Assurance team in Santa Clarita, CA. You will administer and maintain controlled documents, training records, and document control systems to meet quality standards.

The role requires 3+ years in a regulated environment, strong editing skills, and experience with eDMS and ERP systems. You will collaborate with Engineering, Manufacturing, and R&D to ensure timely document changes and CGMB participation.