Quality Assurance Auditor
4 days ago
Position Summary:
This position is responsible for performing quality assurance assessments to ensure the ongoing regulatory compliance for Accumedix and the clients that it serves.
Reporting Structure:
Reports to Manager, RA/QA
Direct Reports:
N/A
Major Responsibilities:
· Responsible for the assessment and documentation of compliance to the various regulatory standards.
· Responsible for the planning and conduct of the internal audits performed for Accumedix and the clients that subscribe to the Accumedix quality system.
· Responsible for assisting with organization and serving as a key contact during the various external audits performed by, but not limited to, FDA, European Notified Body, customers, etc.
Secondary Responsibilities:
· Perform special tasks per request of the Manager of RA/QA; however, it must be noted that this position may not participate in the activities and decisions made regarding the Quality Management System (QMS) to ensure independence is maintained.
Education:
· College degree
Experience:
· A minimum of 2 years of experience in the medical device industry.
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