Medical Device Manufacturing Quality



Manufacturing, Medical & Pharmaceuticals

Jared Haley, Manufacturing Engineer at C-Axis, talks about how InfinityQS® ProFicient™ Statistical Process Control (SPC) software has helped C-Axis with Quality Management. C-Axis is a contract manufacturing facility with a speciality in the Medical Device industry. The company manufactures components for various cardiology devices such as heart valves, defibrillators, pacemakers, and other components for the Medical market. Haley is responsible for developing and improving processes throughout the facility. They currently use ProFicient for data collection as well as SPC analysis.

C-Axis was motivated to choose ProFicient because many of its customers use ProFicient. Haley and his colleagues heard about the benefits of ProFicient from their customers and, after observing the use of ProFicient on customer’s shop floors, they decided to use the tool as well. An additional benefit of C-Axis’ use of ProFicient is that teams can move data back and forth with their customers, allowing for improved quality across the supply chain.

Haley says the results of implementing ProFicient were amazing. The operators have embraced the system because data collection is easy and the data they see is reliable. It has also helped streamline processes. For Haley, ProFicient has added value; it has made his job a lot easier and more efficient, allowing him to focus on other areas.

Haley expects to see return on investment within a year. For Haley, C-Axis’ success is based on quality, therefore quality is a priority. Because of ProFicient’s support for C-Axis’ quality objectives, Haley recommends ProFicient. ProFicient has helped C-Axis improve their quality and meet the demands of its customers.