Document Control Specialist

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.

The Document Control Specialist serves as a key resource for maintaining document integrity throughout the product lifecycle and supports cross-functional teams including Quality, Manufacturing, Engineering, Supply Chain, and Operations to ensure compliance and operational excellence.

Administer and maintain controlled documents within the electronic document control system (MasterControl) for all Lighteum Medical sites.

Manage user access, workflows, templates, and document lifecycle within MasterControl.

Ensure electronic signatures comply with 21 CFR Part 11 requirements.

Ensure integrity, traceability, version control, and security of controlled documents and electronic quality records.

Process document changes including creation, revision, review, approval, issuance, and obsolescence of quality system documentation.

Maintain document control activities for procedures, work instructions, forms, specifications, drawings, travelers, inspection plans, and other quality records.

Coordinate Engineering Change Orders (ECOs) and quality system change requests.

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.

Control the distribution of current revisions and prevent the unintended use of obsolete documents.

Maintain document retention and archival processes in accordance with company policies and regulatory requirements.

Support training activities by ensuring employees are assigned and trained to revised or newly released documents.

Monitor document control metrics such as document turnaround times, overdue approvals, and training completion status.

Support internal, customer, and external audits by providing controlled documentation and quality records.

Participate in management of nonconformance, CAPA/CAR, risk management, supplier quality, and other quality system records as assigned.

Collaborate with Manufacturing and Engineering to ensure production documentation accurately reflects approved manufacturing processes and specifications.

Assist with implementation and continuous improvement of document control processes and quality system workflows.

Coordinate document-related employee training assignments and monitor completion to ensure training compliance prior to document effective dates.

Other duties as assigned.