This is the third in a three-part series on KMC Systems' medical device quality assurance practices.
|Gail Wiegand, Director of Quality Assurance and Regulatory Compliance for KMC Systems.|
Gail Wiegand excels at meeting and delivering the highest
quality standards in medical device development and manufacturing, but her deeper passion is people.
As KMC’s Director of Quality Assurance and Regulatory Compliance, Wiegand reports to the company’s President, Ron Jellison. She manages 20 to 25 medical quality control employees and contractors who interface daily with the other 140 KMC employees of various departments.
Since arriving at KMC from Ohio 13 years ago, Wiegand has integrated her medical quality control skills and insights from a former hospital job many years ago to her position in quality assurance now.
“Having started out in a hospital setting as a Medical Technologist, I know how instrumentation works on a day-to-day basis from a user’s perspective, what it is like to wait for test results from an instrument and how important reliability of that instrumentation is,” she explained.
Wiegand oversees KMC quality compliance inspections, like the “no observations” inspection recently performed by the FDA.
“To put out a good quality product for customers that benefits patients in the end goes a long way, “Wiegand emphasized. “I like to see my customers succeed and have products out in the field that help people. It’s part of who I am.”
She is also proud of managing KMC’s customized Lotus Notes MES with the help of KMC’s Application Specialist, stating that she can typically retrieve any testing or other historical product information in 15 to 20 minutes or less.
A go-getter with a big heart and great sense of humor, Wiegand is often the sole woman working in a male-dominated engineering environment.
“We as women may approach things differently, and may have different perspectives and bring different things to the decision-making process,” Wiegand said. “It’s a good idea to have at least one female in the mix of business decisions and in discussions.”
“I tend to focus on the employees more and make sure they are taken care of. I’m a mom and tend to be a mom around here, too,” Wiegand said.
Read more about KMC's medical quality control here: medical device quality assurance system.
The previous blogs in this three-part series are: