Document Control Specialist

Mainstream Medical Devices, LLC; Austin (TX); Hybrid; USD 45,000 - 65,000; Full time

Job summary

Mainstream Medical Devices, LLC is seeking a Document Control Specialist to manage controlled documents and records in compliance with ISO 13485 and FDA QMSR. You will handle DCOs, label printing, and record storage, while supporting audits and light incoming inspection of parts.

The role requires meticulous attention, 1+ year in a regulated setting, and fluency in English. High school diploma required; MS Office proficiency is expected.

Qualifications

• Experience in a regulated environment with controlled documents.
• Knowledge of ISO 13485 and FDA QMS regulations preferred.
• Proficient in Microsoft Office; able to interpret technical docs.

Responsibilities

• Manage document lifecycle and release change orders (DCOs).
• Maintain Medical Device Files and Batch Records for retrievability.
• Direct storage and archiving of physical and electronic records.
• Support internal/external audits by retrieving documentation.
• Print and verify production labels against specs with zero errors.
• Perform incoming inspection of parts and document results.

Skills

Document Control

QMSR Compliance

Audit Readiness

Labeling & Printing

Incoming Inspection

Microsoft Office

English Fluency

Independent Working

Education

High school diploma

Job description

The Document Control Specialist manages the lifecycle of controlled documents and records in compliance with ISO 13485 and FDA Quality Management System Regulations (QMSR). This role processes document changes, prints and inspects production labels, handles physical and digital record organization and storage, and performs light incoming inspection of parts. Reporting directly to the Quality Director, the ideal candidate thrives in a fast-paced environment, working both independently and collaboratively to maintain strict regulatory compliance.

Essential Functions

• Document Control & QMSR Compliance Process changes: Route, review, and release Document Change Orders (DCOs) which may contain (but not limited to) Standard Operating Procedures (SOPs), Work Instructions, Drawings, Test Protocols/Reports, etc.
• Document Control & QMSR Compliance Maintain records: Ensure Medical Device Files, Batch Records, and other Quality System documents records are organized and retrievable.
• Document Control & QMSR Compliance Storage management: Direct the categorization, archiving, and secure storage of physical and electronic quality records.
• Document Control & QMSR Compliance Audit readiness: Assist the Quality Director during internal and external regulatory audits by retrieving requested documentation and records.
• Labeling & Print Operations Print labels: Execute production label printing according to precise manufacturing work orders.
• Labeling & Print Operations Verify accuracy: Review printed labels against approved specifications to ensure zero errors in text, barcodes, or layout.
• Incoming Inspection Inspect parts: Assist with performing inspection on incoming materials and in-process inspections. Some inspections may occur in a cleanroom environment.
• Incoming Inspection Utilize tools: Visual and mechanical inspection will be required. Tools used includes gauge pins, thread gauges, micrometers, and scales.
• Incoming Inspection Document results: Record inspection data and flag non-conforming materials per established procedures.

Position Requirements

• Education: High school diploma or equivalent education required.
• Experience: Minimum of 1 year of experience in a regulated industry processing or working with controlled documents and records.
• Standards: Basic familiarity with ISO 13485 and FDA QMS regulations is highly preferred.
• Software: Proficient with Microsoft Office Suite (Word, Excel, Outlook).
• Language: Ability to read, write, and speak fluent English to interpret technical specifications and regulatory documents.
• Work style: Proven ability to work autonomously and collaborate effectively as a team player in a fast-paced environment.

Mainstream stands as an equal opportunity employer and is committed to providing fair and equal treatment to its employees and applicants without regard to race, color, national origin, religion, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal state and/or local laws. Mainstream will make reasonable accommodations that are necessary to comply with disability discrimination laws.