Demo

Document Control Specialist

JobRialto
Oneonta, NY Full Time
POSTED ON 2/3/2025
AVAILABLE BEFORE 4/28/2025

Job Summary

The Document Control Specialist is responsible for the administration of quality management system documents and records within Client. This includes initiating document changes, managing distribution, and ensuring compliance with ISO standards, particularly ISO 13485, ISO 9001, and 21 CFR 820. The position supports internal and external document distribution and assists in preparing for audits.

Key Responsibilities

  • Generate, review, and maintain quality system documents, such as procedures, work instructions, job aids, and certificates of conformity, in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards
  • Initiate Change Controls and Document Change Requests to update procedures and processes
  • Collaborate with various departments to update processes and procedures
  • Manage the document review and retention processes
  • Support or lead continuous improvement initiatives for document control processes
  • Assist with other Quality Assurance functions, such as internal audits and CAPAs
  • Perform other duties as assigned

Required Qualifications

  • Associate's or Bachelor's degree
  • 2 years of relevant work experience, preferably in a manufacturing environment
  • Proficiency in Microsoft Office
  • Experience with ISO 9001 or other Quality System standards
  • Highly preferred : knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems
  • Strong organizational skills with the ability to compare documentation using multiple resources
  • Preferred Qualifications

  • Experience using ETQ or other Document Management software
  • Ability to work independently and as part of a team
  • Detail-oriented with a focus on accuracy in execution
  • Location : Oneonta, NY, USA, 13820

    Education : Bachelors Degree

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