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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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