

My Experience in a PAREXEL Audit:
During one of the last weeks of my co-op, I was selected to sit in the front room of an internal PAREXEL audit that Zimmer Biomet held to evaluate some of the quality processes within the company. The PAREXEL was a mock FDA audit to give ZB knowledge on what to anticipate in the next FDA audit. I, along with an Upper Management Team Member, was tasked with "front room" duties for when the auditor had requested a document, procedure, etc. I was able to observe the conversations between many ZB Engineers and/or Management Team Members and the Auditor regarding CAPA's, Evaluations, Procedures, Instructions, Processes, etc. The week I spent in the PAREXEL audit in a room with an Auditor allowed me to further my communication skills within a professional environment. From this experience, I was able to more deeply understand the importance of the jobs of Quality Engineers. I learned about the depths of the evaluations taken for possible nonconforming products in the company and learned the importance of Process Failure Mode Effects Analysis (PFMEA's). I learned about and understood the levels of documents that set standards in a company regarding company goals and government compliance.