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Quality Systems Auditor (preparing documentation)

Company:
Lancesoft Inc.
Location:
Jacksonville, Florida, United States
Posted:
April 20, 2019

Description:

Job title: Quality Systems Auditor

Location: Jacksonville FL

Description:

The Field Action Quality Specialist will be responsible for assisting with the field action process including preparing documentation for the execution of field actions/recalls. Key responsibilities consist of:

• Track field action customer communications for effectiveness verification

• Track global field action status through communication with key business partners

• Prepare and maintain electronic and hard copy field action binders

• Maintain, support compliance of, and improve Field Action processes

• Support internal and external audits, as necessary

This role will work closely with peers within the quality organization located globally.

Qualifications:

• A minimum of a Bachelor's Degree (BS/BA) is required.

• A minimum of two (2) years of professional business experience in a regulated industry is required, preferably in Medical Device.

• Proficiency in Microsoft Word, Power Point and Excel is required.

• Ability to learn and apply new skills quickly; highly motivated to learn and develop new processes.

• FDA and ISO regulations knowledge. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001 is preferred.