Device Firms Struggle To Find Qualified Quality Assurance Professionals

CDRH Director Ulatowski Recommends Manufacturers Look For Certain Skills

From the July 2007 issue of "The Silver Sheet"

Finding well-trained, highly skilled professionals to fill a variety of quality assurance (QA) positions is proving increasingly difficult for a large number of medical device manufacturers, leading some to encourage people interested in the quality profession to make more use of specialized education and certification programs.

“It just seems like there aren’t enough people to fill the funnel. There’s a big gap,” says Don Middlebrook, VP of regulatory affairs and quality assurance at Pleasanton, Calif.-based Thoratec.

“If you look at the people who have the big [QA] jobs at the moment, they’re all baby boomers, and as they retire and the shifts occur and people are moving around and filling those jobs, it’s creating a vacuum at the lower level,” he says.

Although Thoratec – which manufactures ventricular-assist devices such as the HeartMate XVE – offers QA professionals excellent wages and the chance to work at a company that has seen its sales balloon over the past decade from $2 million to more than $200 million, the firm still has trouble attracting the people it needs, Middlebrook says.

“It’s just hard to recruit. Finding good people with practical experience, at least enough of it to make an impact and to fill the job and to meet the requirements of the job, is difficult,” he says. “We have positions – for example, quality engineer [and] quality manager jobs – that sometimes take four or five months or longer to fill.”

Middlebrook isn’t alone. All across the nation manufacturers big and small are having a tough time finding individuals with the proper credentials to fill key quality positions.

“I do find that 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, sustainability & product security for Philips Medical Systems, an Andover, Mass., company that manufactures imaging systems.

This article continues in the July 2007 issue of "The Silver Sheet"

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