Document Control Specialist
$62,400–$83,200 year
On-siteSan Diego, California, United States
Job Summary
Administer and maintain controlled documents within the electronic document control system (MasterControl) for all Lighteum Medical sites, managing user access, workflows, templates, and document lifecycles. Ensure electronic signatures comply with 21 CFR Part 11 requirements while maintaining integrity, traceability, version control, and security of quality records. Process document changes including creation, revision, review, approval, issuance, and obsolescence for procedures, work instructions, forms, specifications, drawings, travelers, and inspection plans. Coordinate Engineering Change Orders (ECOs) and quality system change requests, verifying accuracy and preventing the unintended use of obsolete documents. Support internal, customer, and external audits by providing controlled documentation and quality records, and assist with nonconformance, CAPA/CAR, and risk management activities. Collaborate with Manufacturing and Engineering to ensure production documentation accurately reflects approved processes, monitor document control metrics, and support training assignments for revised documents. This onsite position at the San Diego facility offers an hourly rate of $30.00 to $40.00.
Required Qualifications
- High School diploma or equivalent
- Associate's or bachelor's degree in Engineering, Business Administration, Life Sciences, or a related field
- Minimum of 2 years of document control or quality systems experience in a regulated manufacturing environment
- Experience working within an ISO 13485 Quality Management System
- Understanding of ISO 13485 document and record control requirements
- Experience in medical device manufacturing or medical device component manufacturing
- Experience with eQMS software systems such as MasterControl
- Strong written and verbal skills
- Ability to manage multiple document changes simultaneously while meeting deadlines
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