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Document Control Specialist

Document Control Specialist

Summary

Owlet is growing and on the search for Document Control Specialist to organize and maintain all controlled Quality System documents and affiliated Quality Records in accordance with 21 CFR 820 and ISO13485 requirements

Essential Functions:

  • Act as a liaison with Engineering, Marketing, Sales, Shipping, Regulatory, Quality and Manufacturing to control, issue, update and cancel documents used in the Quality Management system
  • Maintain technical files for medical products and assist in the design transfer of products from design to manufacturing
  • Assign new part numbers, Change Management (CM) Record numbers, and deviation numbers
  • Process Change Management Files according to procedure(s), ensuring appropriate formatting, document classification, cross references, approvals, and proper record keeping in CM forms
  • Monitor and facilitate timeliness of CM approval in accordance with the Signature Authority Matrix
  • Issue Change Notifications to internal and external customers on approval of CMs
  • Coordinate translations
  • Proficiently utilize the company’s document control and management system
  • Provide training on Good Documentation Practices and Document Change Control as needed
  • Support internal and third-party audits
  • Maintain library of external standards
  • File company training records
  • Assist with minor modifications of engineering drawings using Solid Works
  • Other Quality System improvement initiatives as assigned

Qualifications:

  • 2+ years of experience performing similar work in an FDA regulated environment in the medical device industry preferred
  • Advanced knowledge of MS Word and MS Excel
  • Knowledge & ability to read part drawings and electronic device files
  • Knowledge of ISO 9001, EN ISO 14971 and ISO 13485 Requirements
  • Excellent organizational skills
  • Exceptional communication skills, ability to work with all levels of the organization
  • Self-Starter, takes initiative
  • Ability to perform duties with guidance, with minimal direct supervision
  • Detail oriented and able to catch obvious typographical errors and inconsistencies in documents

 

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