Document Control Specialist
Mexicali, Baja California
VACANCY SUMMARY
The Document Control Specialist is responsible for maintaining and administering the Quality Management System (QMS) documentation in accordance with ISO 9001/ISO 13485, applicable regulatory requirements, and company procedures across all Lighteum Medical sites.
RESPONSIBILITIES
- Ensure all documentation complies with ISO 9001 / ISO 13485 requirements and internal quality procedures.
- Verify document accuracy, formatting, revision history, and approval requirements before release.
- Maintain document retention and archival processes.
- Control the distribution of current revisions and prevent the unintended use of obsolete documents.
- Support training activities by ensuring employees are assigned and trained.
REQUIREMENTS
- Bachelor’s degree in Engineering, Business Administration, or a related field.
- 2 years of document control or quality systems experience in a regulated manufacturing environment.
- Experience working within an ISO 13485 Quality Management System.
- Experience in medical device manufacturing or medical device component manufacturing.
- Experience with eQMS software systems such as MasterControl.
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