Quality Assurance Engineer (Columbus, Ohio)

About our Client & the role:
Our products comply with applicable regulatory requirements as established by ISO 13485, U.S. Food & Drug Administration (21 CFR Part 803, 806, 820), MDR 2017/745, CMDR registered Quality Management Systems. The person in this position will work closely with the VP of Product Development to ensure that the quality system is implemented, monitored and maintained in accordance with all applicable regulatory requirements.

Two will be hired. All in all, Quality Systems in place could be better, could be implemented better, and new leadership is passionate about achieving!

Responsibilities:
Assist in the maintenance of an effective Document Control Management system, including relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the proofing, filing, copying, scanning, archiving, retrieval, and maintenance of all controlled documents and records required...