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Document Control Specialist

2 months ago

Loveland, Colorado, United States Ledgent Full time

Job Summary:

The Document Control Clerk will be responsible for managing the company's document control system in compliance with ISO 9001, ISO 13485, and other relevant standards and regulations.

Key Responsibilities:

  • Manage the creation, review, revision, approval, filing, maintenance, and retrieval of documents and records necessary for the Quality Management System (QMS) and various company processes.
  • Collaborate with team members to address discrepancies or errors, revising documents as necessary.
  • Maintain all documentation related to CAPA, NCMR, complaints, audits, equipment, calibration, etc., in accordance with company policies.
  • Act as the Training Coordinator within the eQMS software, reviewing completed training records for accuracy and completeness.
  • Track calibration schedules and ensure equipment critical to production, verification, validation, or quality remains calibrated.
  • Issue NCMRs for out-of-specification parts, sub-assemblies, and assemblies, and track the progress of NCMRs, aiming for material disposition and report closure within one week.
  • Issue CAPAs for systemic issues or complaints, and monitor CAPA progress, ensuring timely completion without unnecessary delays.

Requirements:

  • Minimum high school diploma or GED required; associate's or bachelor's degree preferred.
  • Prior experience in Document Control; experience in the IVD or medical device industry is preferred.
  • Proficiency in MS Word and Excel.
  • Strong communication skills and ability to build positive relationships across all levels of the organization.

Equal Employment Opportunity:

Ledgent is an equal opportunity employer and welcomes applications from all qualified candidates. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws.