Quality Assurance Associate I

Job description

Description Responsible for working with Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, and other company personnel to perform Quality Assurance activities. Works with the team to ensure continued compliance with ISO 13485 and FDA’s Quality Standard Regulation (21 CFR 820). RESPONSIBILITIES: - Assist the Field Report Coordinator in the processing of product complaints, including receipt of information from field personnel, completion of reportability decision trees, completion of risk assessments, and review of build documentation. - Coordination of product returns associated with product complaints, expiring, and unused product. - Assist with the supplier qualification and monitoring program. - Support internal and external audits. - Support periodic management review of quality metrics. - Perform incoming, in-process and final inspections according to schedule. ADDITIONAL RESPONSIBILITIES: - Perform document control activities. - Initiate and own nonconformances and track activities to closure. - Attend conferences and seminars to understand and extend company awareness of up-to-date activities in the Quality Assurance field. - Performs other duties and projec...