Job Description:

Under the direction of the department management, the Quality Analyst will perform a variety of functions within Quality Assurance. Assists in establishing a library of appropriate messaging to be used in correspondence with regulators worldwide. This includes, but is not limited to: compiling language, reviewing and managing correspondence with the various teams responsible for responding to regulators regarding SJM products. Specifically, this correspondence is related, but not limited to: follow up questions on vigilance reports and follow up questions/ correspondence on field actions (FSCAs). This role maintains this agreed upon library of messaging for use as needed going forward and will partner with the individuals responsible for preparing the correspondences. Perform data analysis for medical device post market surveillance activities and data trending. Looking for candidates with an engineering background. This role will entail complaint handling activities including data analysis.