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Senior Quality Systems Specialist

My medical device client located in Irvine, CA is looking for a Quality Systems Specialist to join their team! This position can range from senior to principal level depending on years of experience. The quality systems specialist will be responsible for supporting quality systems administration within the company, maintaining department and company records and files, and organizing regular CAPA review board, complaint, and audit findings.

Responsibilities:

-Ensures Quality System records are filed, maintained and retained in compliance with companies QMS

-Conducts internal audits and supplier audits, prepares and completes audit plans, and audit reports

-supports regulatory inspections and external audits

-conducts quality labelling review

Requirements:

-bachelor's degree or higher

-Certified Auditor

-5+ years' experience in Quality Systems administration and auditing within medical device FDA regulated industry

-Knowledgeable in 21CFR820, ISO 13485:2016, SOR 98/282

-Experience conducting internal audits and supplier audits

Sthree US is acting as an Employment Agency in relation to this vacancy.