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Company: Advanced Bifurcation Systems Inc.
Location: Livermore
Posted on: January 5, 2022

Job Description:


Reporting to the Director, Quality Control & Assurance, the Document Control Specialist, working with the QA Engineer, will have responsibility for developing, managing and maintaining ABS's documentation control system in compliance with ABS's Quality Management System (" QMS ").


BSc, BA, AA, or equivalent education preferred and relevant professional experience, including operational experience in developing and managing document control systems, and in the preparation of FDA and CE Mark filings, in the medical devices sector (ideally in the cardiology field). Experience: ideally 5 + years required.


Reporting to the Director, Quality Control & Assurance and working with fellow team members, developing, managing and maintaining documentation control system in compliance with ABS's QMS.
Responsible for ensuring that ABS's documentation and documentation control system (i) meets all quality systems regulatory requirements; (ii) meets or exceeds documentation control system standards typical for medical device companies similar to ABS; (iii) is efficient with respect to the utilization of ABS resources and ABS's QMS; and (iv) work cooperatively and effectively with internal team members and external partner
Other duties and responsibilities as mutually agreed.


Innovative, Creative, Team Player
Strong written and verbal communication skills
Ability to work in a rapidly changing and evolving environment

Salary Range: $70,000 - $120,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation

Keywords: Advanced Bifurcation Systems Inc., Livermore , DOCUMENT CONTROL SPECIALIST, Other , Livermore, California

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