Quality Assurance Specialist - Device History Record (DHR)

Job description

Job Title Quality Assurance Specialist - Device History Record (DHR) Job Description: Quality Assurance Specialist – Device History Record This individual ensures Device History Records meet regulatory and internal requirements and provide adequate verification of compliance to the product’s engineering specifications. Your role: - The Quality Assurance Specialist is a member of the Operations Quality team in Latham which ensures compliance with legal, regulatory and international standards as they apply to Latham’s Quality Management System. This role is critical in ensuring that manufacturing records for components of medical devices are compliant with applicable standards and regulations prior to releasing product from the factory. - The employee reviews electronic and paper records to ensure completeness, accuracy and compliance to defined specifications and requirements. Nonconformances are identified and corrected prior to allowing shipment of product from the facility. - This position reports into the Quality Management System Manager. The employee will work directly with Operations, Quality Engineer and Quality Control teams to make sure information is accurately and comple...