The Role of Quality Assurance in Medical Device Manufacturing

KMC Systems Director of Quality Assurance and Regulatory Compliance Gail Wiegand discusses how the Quality Assurance team aids in the medical device manufacturing process.

Video Transcription:

What are the roles and responsibilities of the quality group?

The quality assurance group at KMC has a pretty large umbrella. We support all of the manufacturing programs from acceptance of product to dealing with supplier issues to defective materials, helping to support our customers with whatever their needs are for data or an understanding of how we do things at KMC, helping the teams understand what their roles are on the manufacturing floor, working through process issues and continuous improvement activities.

Gail Wiegand KMC Systems Quality ControlIn engineering, we support the software quality assurance and design assurance roles, and help the teams make sure that they’re working to the compliance practices that they need to for design controls, as well as ensuring that products are fully verified or validated before they go into the marketplace.

We also have groups receiving inspection personnel that are responsible for making sure good product gets to the floor and that the bad product stops at the door, and deal with the supplier issues. They, along with supplier quality engineering help resolve any issues that we have with defective material.

Also, in support of the quality management system, we have a design application specialist who designs and maintains all of our applications in our manufacturing execution system, as well as supporting us with any data needs that we have for the business.

And even our administrative assistant within our department helps play a role in the quality management system maintenance by maintaining our standards library and all of our quality procedures and forms.

Topics: medical device manufacturing, medical device quality assurance, medical manufacturing