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Open nowPosted 7 hours ago

Document Control Specialist

Workable (global search)107,808 open roles

Where
San Jose, CA, United States
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Your applicationOpen nowDocument Control SpecialistWorkable (global search) · San Jose, CA, United States

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The clock on this job

Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market. Workable (global search) postings stay open a median of 2 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted 7 hours ago

Workable (global search) median: 2 days open

The posting

The Document Control Specialist is responsible for managing and maintaining the integrity of documentation and record-keeping in compliance with ISO 13485:2016 standards. This role involves handling quality plans, production documentation, inspection reports, calibration activities, and supplier-related records, ensuring that all documentation is accurate, up-to-date, and readily accessible within the IQMS system.

Duties:

  • Manage and update quality plans, in-process documents, and drawings in the IQMS system.
  • Ensure accurate and timely upload of supplier-related documents to the IQMS system.
  • Review and save last-shot paperwork from production runs.
  • Verify batch production records for completeness and accuracy.
  • Perform COC (Certificate of Conformance) verification and authorization.
  • Ensure proper storage and traceability of material certificates.
  • Verify and save inspection reports for compliance with company standards.
  • Handle supplier-related documentation, ensuring timely uploads and updates in the IQMS system.
  • Maintain compliance with ISO 13485:2016 requirements and company quality standards.
  • Identify opportunities for process improvement in document control and record management systems.

When Required:

  • Participate in Material Review Board (MRB) activities, including quarantine, meeting coordination, disposition, and record-keeping.
  • Coordinate calibration activities for tools and ensure up-to-date calibration records.

Requirements

Skills and Requirements:

  • High school diploma or equivalent required;
  • Ability to read part drawings and translate dimensional and cosmetic requirements from a drawing into written work instructions for machine operators.
  • One to three years of experience in document control, preferably in a manufacturing environment.
  • Experience working in an ISO 13485:2016-certified company is a plus.
  • Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
  • Strong attention to detail and organizational skills.
  • Ability to work collaboratively across departments and with external suppliers.
  • Familiarity with quality management processes.
  • Must be able to read, write, and verbally communicate in English.

Benefits

Standard Health, Dental, Vision Benefits.

Generous PTO.

401K Match.

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