About The Position

Document Control Associate will ensure that all manufacturing documentation for medical devices are properly created, maintained, and compliant with regulatory standards.

Requirements

  • Bachelor's Degree (e.g., Manufacturing, Engineering, Sciences, Business Administration, etc.).
  • 3-4 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, written and spoken)
  • Availability to work any shift (1st,2nd,3rd)

Responsibilities

  • Ensure that all documents are up to date, accurate, and in compliance with relevant regulatory standards.
  • Assist in the creation of documents for product specifications, protocols, and history files.
  • Support the compliance of manufacturing documentation with regulatory requirements and internal quality standards.
  • Coordinate with the Quality Assurance (QA) team to ensure the manufacturing processes and documentation adhere to industry regulations and company policies.
  • Assist in internal audits and document reviews to ensure compliance with regulations.
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