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Quality Specialist
A medical device company, located northeast of Pittsburgh, PA, is seeking a Quality Specialist. Responsibilities: Responsible for maintaining a Current Good Manufacturing Practice (cGMP) compliant Quality Management System for a Medical Device manufacturer's implemented systems, processes, equipment and materials compliance to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, MDR 2017/745, and ISO 13485 requirements. Track, document, and report any changes in, or improvements to, the Quality System. Inspect quality processes, products, device history records, and personnel in all production areas regularly to ensure compliance. Perform trend analysis on production data. Investigate and


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