Control de Documentos Analista (Calidad, Manufactura)

Vapotherm Manufactures medical devices for respiratory therapy.

Job Description – Document Control Associate | Medical Devices

The Document Control Associate supports the Quality team by maintaining an accurate and compliant document control system for a medical device manufacturing environment. This role ensures controlled

documents are current, properly distributed, and aligned with ISO 13485, FDA QSR, and internal quality system requirements. The position collaborates closely with Quality, Engineering, and Operations to support change control, training compliance, and documentation management.

Key Responsibilities

1. Control, distribute, and maintain current revisions of SOPs, WIs, drawings, and quality documents, ensuring obsolete versions are removed.
2. Support change control processes (ECOs) and document revisions in compliance with ISO 13485 / FDA requirements.
3. Maintain and manage the Document Control system and database for fast and accurate document retrieval.
4. Manage and track training records, onboarding documentation, and compliance for the Mexico plant.
5. Provide documentation and administrative support to Quality Inspectors and Engineering teams, including basic document updates.