Senior Quality Engineer -Complaints
CurrentReview and evaluate all possible feedback received by Senseonics to identify whether a Senseonics customer complaint has been made. Responsible for processing complaints and incident (MDR, Vigilance) reports to assure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner. Establish and maintain complaint files and databases for all customer complaints in accordance with U.S. and international regulations. Coordinate with Customer Service, Engineering, Quality, and any complaint investigation and analysis personnel to gather root cause determinations and properly document complaint closure. Possible involvement with and/or support of internal and external audits of activities related to handling and documenting customer complaints. Maintain an understanding of information/data required to be collected for technical and AE complaints to assure compliance with regulations and directives.