Description
The Client:The Client is a innovative global leader in less invasive medical device and surgical products. They have seen year over year growth and our excited to experience continued success globally.
The Role:
As a Quality Assurance Manager you will be working cross-functionally with management teams to update and maintain a new Quality System to ensure compliance of all Quality documents.
Responsibilities:
Manage CAPA Program
Manage Internal Audits in compliance to FDA/ISO/MDD regulations
Develop Company Audit Schedules and Documentation
Develop, Implement and Train Staff on Standard Operating Procedures
Support the Quality Compliance Department
Requirements:
B.S. in relevant field
5-7 years medical device industry experience
Strong knowledge of ISO-13485
Strong knowledge of 21 CFR Part11
ASQ - CQA preferred
To find out more about Real please visit www.realstaffing.com