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Meet Madeline Roche, the New
Quality Manager at BC Group
With four months into her new position as BC Group’s new Quality Manager, Madeline Roche is already bringing fresh perspectives to BC Group’s quality system while learning the basis on which they were formed. Madeline graduated from Northwestern University with a degree in Biomedical Engineering. She’s been in Quality roles for 14 years, with her first job working as a Validation Engineer for a small company that made dialysis machines in the Chicagoland area. She switched to the pharmaceutical manufacturing industry for 11 years at facilities producing radiological imaging agents and biopharmaceuticals. Both sites were part of large companies with multiple operations around the world. Madeline held roles in Validation, Quality Assurance and Quality Control. During this time, she also earned an MBA from Webster University and became a six-sigma green belt.
As the new Quality Manager, Madeline oversees BC Group’s quality system which maintains the company’s ISO and FDA standards. Madeline's immediate plans for the organization include improvements to the internal auditing program and a new, more robust training program to facilitate continued growth. Madeline has already started working with multiple departments on improving their documentation and she hopes to continue to foster an environment of quality focus and a continual improvement mindset.
We asked Madeline about the importance of quality for a company, “We have all experienced a time when we were frustrated by a product that did not work correctly or did not meet our expectations. Quality is important because making a high-quality product leads to satisfied customers.” Madeline also pointed out that an excellent quality program is especially important for OEMs because in the medical industry, quality is even more important as products help ensure the correct operation of hospital equipment, potentially improving a patient’s treatment.
When a biomed is purchasing test equipment, Madeline recommends ensuring that a firm is ISO certified and FDA registered when applicable, as certain systems must be in place and an accreditation body will confirm them in an audit. Madeline stated, “This takes the burden off the customer as they can trust in the review already performed by the independent party.”
When not at work, Madeline enjoys spending time with her family. She has two young children who keep her and her husband busy and entertained. As a family, they enjoy traveling together and seeing new places. In 2016, they took an Alaskan cruise and toured the White House. Madeline and her family will spend this holiday season in New Zealand and Australia.
Click here to find out about BC Quality Programs.
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