Document Control Specialist 1

4 weeks, 1 day ago
Full-time
Entry Level
Technical Writing and Documentation
Cadwell

Cadwell

Cadwell provides cutting-edge neurodiagnostic and neuromonitoring equipment with market-leading customer support, empowering healthcare professionals to broaden their expertise in EMG, NCS, and NMUS.

Health Care Providers & Services
51-250
Founded 1979

Description

  • Manage current and historical documentation repositories in accordance with company and regulatory requirements.
  • Maintain accurate and complete version control across document control systems.
  • Review and process engineering changes, ensuring updates are clearly documented using standard good documentation practices.
  • Implement bills of materials in the company ERP system.
  • Process part number requests and create item records in the ERP system.
  • Prepare and process regulatory compliance documentation in accordance with 21 CFR Part 11 and company requirements.
  • Support internal and external audits by providing requested documentation and demonstrating document control system accuracy.
  • Ensure document control activities follow written processes and comply with ISO 13485 and other applicable regulatory requirements.
  • Execute small documentation-focused projects.
  • Perform other duties as assigned.

Requirements

  • Associate’s degree in a technical field or equivalent work experience.
  • At least 1 year of relevant document control experience or related work.
  • Working knowledge of version control best practices.
  • Working knowledge of engineering change control processes.
  • Preferred working knowledge of good documentation practices (GDP).
  • Preferred working knowledge of ERP systems and BOM structures.
  • Ability to work as part of a cross-functional team with a professional, solutions-oriented approach.
  • Ability to manage more than one effort at once.
  • Strong attention to detail with a high degree of accuracy.
  • Preferred experience working in a regulated environment, ideally in a medical, engineering, or quality-focused industry.

Benefits

  • Salary range of $22 to $33 USD per hour.
  • Equal opportunity employer commitment.
  • Accommodation support for applicants who need special assistance to apply.
  • Travel may be required for the role.
  • Work outside normal business hours may be required at times to meet business needs.

Interested in this position?

Apply directly on the company website

Apply Now

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