Document Control Specialist — MedTech QA with 9/80 Schedule

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R; Santa Clarita (CA); On-site; USD 48,000 - 52,000; Full time

Job summary

huMannity Medtec in Santa Clarita, CA is seeking a Document Control Specialist to join our Quality Assurance team. You will administer and maintain controlled documents, records, training documentation, and document control systems in compliance with company requirements and quality standards.

The ideal candidate thrives in a fast-paced environment, collaborates across Engineering, Manufacturing, Quality, and R&D, and has a strong understanding of document control in regulated industries.

Qualifications

• 3+ years in document control or quality systems in regulated environments.
• Strong attention to detail and accuracy.
• Proficient with Microsoft Office (Word, Excel, PowerPoint, Visio).
• Experience with electronic document management systems.
• Experience with ERP systems.
• Able to review technical drawings and specifications for compliance.
• Excellent organizational and communication skills.
• Ability to work independently and manage multiple priorities.

Responsibilities

• Manage controlled documents, records, and document control systems in accordance with company procedures and quality requirements.
• Review documents for completeness, accuracy, formatting, and compliance with established standards.
• Edit documents to correct formatting, grammar, typographical, and data inconsistencies.
• Process document change requests and create change orders in a timely manner.
• Coordinate with Engineering, Manufacturing, Quality, and R&D teams to ensure timely completion of document changes.
• Monitor document workflows and follow up on outstanding actions.
• Maintain document logs and records to ensure data integrity and traceability.
• Participate in Change Control Board (CCB) meetings and support change management activities.
• Conduct periodic document reviews and ensure compliance with review schedules.
• Compile metrics, generate reports, and maintain document control KPIs.
• Assign training requirements and ensure training completion by the appropriate personnel.
• Maintain training records and training matrices.
• Monitor overdue training activities and send reminders as needed.
• Enter released parts, fixtures, and assemblies into the inventory management system.
• Issue, audit, and archive laboratory notebooks.
• Update and maintain SOPs related to document control and training.
• Serve as a subject matter expert for document control and training processes.
• Maintain records in accordance with company record retention requirements.
• Support other Quality Assurance activities as assigned.

Skills

Attention to detail

MS Office

eDMS

ERP systems

Documentation review

Independent worker

Communication skills

Tools

ERP systems

eDMS

Job description

huMannity Medtec in Santa Clarita, CA is seeking a Document Control Specialist to join our Quality Assurance team. You will administer and maintain controlled documents, records, training documentation, and document control systems in compliance with company requirements and quality standards.

The ideal candidate thrives in a fast-paced environment, collaborates across Engineering, Manufacturing, Quality, and R&D, and has a strong understanding of document control in regulated industries.