Manufacturing Documentation Support

Manufacturing Documentation Support role plays a key part in ensuring that all manufacturing documentation for medical devices is properly created, maintained, and compliant with regulatory standards. Expertise in reviewing validation data on manufacturing equipment, specifically in CSV.

Responsibilities:
Develop, review, and maintain manufacturing documentation, including Standard Operating Procedures (SOPs), Work Instructions, Batch Records, and Equipment Maintenance Logs.
Ensure that all documents are up to date, accurate, and in compliance with relevant regulatory standards.
Assist in the creation of controlled documents for product specifications, testing protocols, and design history files.
Requisitos:
Associate's degree or higher in a relevant field (e.g., Manufacturing, Engineering, Sciences, Business Administration, etc.).
2-4 years of experience in a manufacturing or quality assurance role in the medical device industry, with a focus on documentation or regulatory compliance.
Bilingual (English & Spanish)