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Device Firms Struggle To Find Qualified Quality Assurance Professionals

This article was originally published in The Silver Sheet

Executive Summary

SKILLED QUALITY ASSURANCE PROFESSIONALS who have the training necessary to help medical device manufacturers comply with FDA’s regulatory requirements are becoming hard to find despite the promise of good wages and benefits, some firms say. "Every [QA] position that we have posted, no matter what level the position, almost always seems to take us at least three months to fill," says Elisabeth George, VP of quality & regulatory at Philips Medical Systems. Now, industry is turning to colleges and universities to help fill the need for QA experts by urging schools to create new quality-related programs while strengthening existing ones. Meanwhile, CDRH Compliance Director Tim Ulatowski recommends that firms choose their QA professionals wisely and offers tips on the skills that those in quality should possess. "Within the first five minutes of meeting with a [QA] team from industry [I] get a sense of whether or not they understand their roles and responsibilities, and they understand their product," he says...

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