Business ProfileforQuality Auditing

4 years ago, I was hired to manage the QMS for a large medical device manufacturing company. That year, I hired Quality Auditing LLC to conduct an internal audit of my company’s QMS to establish a baseline for the gaps in our QMS. Their auditor identified 33 observations, including 17 NCs. I had my work cut out for me… I spent the next year fixing these identified problems and closing the gaps in our QMS. The next year, we hired Quality Auditing LLC again to conduct another internal audit. That year, they made only 6 observations, including 2 NCs. Over those two years, I had now worked with two different auditors on the Quality Auditing LLC team and I had learned so much from them. They came with years of industry experience and they provided a lot of masterful advice and insight. It was clear that everything I had learned from these auditors really sank in, because when we hired Quality Auditing LLC in my third year, I delivered the first clean internal audit in my company’s history. Not only was my company proud of these exceptional results, but I was proud of my personal and professional growth having worked and learned from Quality Auditing LLC. A few weeks ago, my company received notice of a surprise audit by the FDA, but in the face of this audit, I felt prepared and ready. That week, I delivered the first 100% clean FDA audit in my company’s history. The success of this audit can absolutely be attributed to working with and learning from the Quality Auditing LLC team over these past few years. It’s clear that the road to achieving world-class quality can take significant time and effort, and I am incredibly grateful to the Quality Auditing LLC team for helping to carve the path for us along the way.